American Surgical Company: Product packaging defective compromising sterility

Agency Publication Date: May 26, 2016

Affected Products

Product: American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot Number:/ 2015/08 BH 2015/09 BP 2015/10 BM 2015/11 BL 2015/12 AX 2015/12 CR 2016/01 AN

Lot Numbers:

Number

Product: American Surgical Delicot 30mm x 70mm Ref: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot number: 2015/08 BH 2015/09 BP 2015/10 BM 2015/11 BL 2015/12 AX 2015/12 CR 2016/01 AN 2015/08 BZ 2015/10 AG 2015/09 AW 2015/10 CD 2015/11 AZ 2015/11 BT 2015/12 AY 2015/11 BH 2015/12 CO 2015/12 DD

Lot Numbers:

number

Product: American Surgical Americot Blue 1/4" x 1/4" Ref Number: 20-01S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot number: 2015/09 AB 2015/12 BS 2015/12 BN 2016/01 AC

Lot Numbers:

number

Product: American Surgical Americot Blue 1/2" x 1/2" Ref Number: 20-04S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 CM 2015/09 AJ 2015/10 BI 2015/11 AY 2015/12 CJ

Lot Numbers:

numbers

Product: American Surgical Americot Blue 1/2" x 1" Ref Number: 20-05S Product Usage: Neurosurgical and Nonneurosurgical Sponges Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AB

Lot Numbers:

numbers

Product: American Surgical Americot Blue 1/2" x 1.5" Ref Number: 20-06S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BR 2015/12 BO 2015/12 BU

Lot Numbers:

numbers

Product: American Surgical Americot Blue 1/2" x 3" Ref Number: 20-07S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/12 CG

Lot Numbers:

numbers

Product: American Surgical Americot Blue 1" x 3" Ref Number: 20-10S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AL 2015/11 BZ 2015/12 CC 2016/01 AB

Lot Numbers:

numbers

Product: American Surgical Americot Blue 3/8" x 3/4" Ref Number: 20-14S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 CU 2015/11 BK 2015/12 DB

Lot Numbers:

numbers

Product: American Surgical Americot Blue 1/8" x 1/8" Ref Number: 20-19S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2016/01 AD

Lot Numbers:

numbers

Product: American Surgical Americot Blue 3/8" x 3/8" Ref Number: 20-22S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AR 2015/11 BX

Lot Numbers:

numbers

Product: American Surgical Americot Blue 3/8" x 2" Ref Number: 20-26S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BJ

Lot Numbers:

numbers

Product: American Surgical Americot Blue 1/4" x 1.5" Ref Number: 20-30S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 BL

Lot Numbers:

numbers

Product: American Surgical Americot White 1.5 cm x 5.5 cm Ref Number: 20-31SW Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/11 AV 2015/12 BC

Lot Numbers:

numbers

Product: American Surgical Americot Blue 1/2" x 2" Ref Number: 20-32S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 CO 2016/01 AH 2016/01 AE

Lot Numbers:

numbers

Product: American Surgical Ultracot 5 mm x 8 mm Ref Number: 23-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 CG 2015/09 CA

Lot Numbers:

numbers

Product: American Surgical Ultracot 5 mm x 8 mm (Glassine) Ref Number: 23-01G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AJ 2015/10 CP 2015/11 BM

Lot Numbers:

numbers

Product: American Surgical Ultracot 5 mm x 13 mm (Glassine) Ref Number: 23-02G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 AY 2015/11 AA 2015/12 BB

Lot Numbers:

numbers

Product: American Surgical Ultracot 10 mm x 13 mm (Glassine) Ref Number: 23-03G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AH 2015/10 CE 2015/11 AB

Lot Numbers:

numbers

Product: American Surgical Ultracot 15 mm x 20 mm Ref Number: 23-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/12 BP

Lot Numbers:

numbers

Product: American Surgical Ultracot 15 mm x 20 mm (Glassine) Ref Number: 23-04G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 CJ 2015/11 AC 2015/12 BQ

Lot Numbers:

numbers

Product: American Surgical Ultracot 6 mm x 50 mm Ref Number: 23-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 CT

Lot Numbers:

numbers

Product: American Surgical Ultracot 9 mm x 50 mm (Glassine) Ref Number: 23-07G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 CF 2015/12 AO

Lot Numbers:

numbers

Product: American Surgical Ultracot 13 mm x 60 mm Ref Number: 23-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AP

Lot Numbers:

numbers

Product: American Surgical Ultracot 13 mm x 60 mm (Glassine) Ref Number: 23-08G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AI 2015/11 AD 2015/11 BU

Lot Numbers:

numbers

Product: American Surgical Ultracot 20 mm x 60 mm Ref Number: 23-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 CJ

Lot Numbers:

numbers

Product: American Surgical Ultracot 20 mm x 60 mm (Glassine) Ref Number: 23-09G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 AZ 2015/10 AD 2015/10 BQ 2015/10 CQ 2015/11 AE

Lot Numbers:

numbers

Product: American Surgical Ultracot 30 mm x 70 mm Ref Number: 23-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/11 CG

Lot Numbers:

numbers

Product: American Surgical Ultracot 30 mm x 70 mm (Glassine) Ref Number: 23-10G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AE 2015/10 BP

Lot Numbers:

numbers

Product: American Surgical Ultracot 15 mm x 15 mm (Glassine) Ref Number: 23-12G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AF

Lot Numbers:

numbers

Product: American Surgical Ultracot 30 mm x 90 mm (Glassine) Ref Number: 23-15G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 BK

Lot Numbers:

numbers

Product: American Surgical Ultracot 70 mm x 10090 mm Ref Number: 23-24 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BZ 2015/11 BA

Lot Numbers:

numbers

Product: American Surgical Cotton Balls-Strung 1/4" Ref Number: 30-00 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 CM 2015/11 AO 2015/12 BR

Lot Numbers:

numbers

Product: American Surgical Cotton Balls-Strung 3/8" Ref Number: 30-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BN

Lot Numbers:

numbers

Product: American Surgical Cotton Balls-Strung 1/2" Ref Number: 30-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BN

Lot Numbers:

numbers

Product: American Surgical Cotton Balls-Strung 3/4" Ref Number: 30-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 AD 2015/11 AP 2015/12 CE 2015/12 DA

Lot Numbers:

numbers

Product: American Surgical Cotton Balls-Strung 1" Ref Number: 30-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 AI 2015/09 AA 2015/09 CL 2015/10 AT 2015/11 CH 2015/12 CB 2015/12 AJ

Lot Numbers:

numbers

Product: American Surgical Cotton Balls-Strung 1.25" Ref Number: 30-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 CK 2015/10 BF

Lot Numbers:

numbers

Product: American Surgical Cotton Balls-Strung 1/8" Ref Number: 30-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: Lot Number 2015/11 AL 2015/12 AS 2015/12 BD 2015/12 DJ

Lot Numbers:

numbers

Number

Product: American Surgical Cotton Balls-Non-Strung 3/4" Ref Number: 31-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AO

Lot Numbers:

numbers

Product: American Surgical Cotton Balls-Non-Strung 1" Ref Number: 31-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 BR

Lot Numbers:

numbers

Product: American Surgical Cotton Balls-Non-Strung 1/8" Ref Number: 31-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/12 AW

Lot Numbers:

numbers

Product: American Surgical Tonsil Sponges 1" Large Ref Number: 50-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/12 BE

Lot Numbers:

numbers

Product: American Surgical Ray-Cot 1/4" x 1/4" Ref Number: 60-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 AX 2015/10 BU 2015/10 BZ 2015/11 BN 2015/12 BK 2015/12 AF 2015/12 CL

Lot Numbers:

numbers

Product: American Surgical Ray-Cot 1/4" x 3" Ref Number: 60-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/12 AA

Lot Numbers:

numbers

Product: American Surgical Ray-Cot 1/2" x 1/2" Ref Number: 60-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 AO 2015/09 BU 2015/11 BW 2015/12 BX 2015/12 DN

Lot Numbers:

numbers

Product: American Surgical Ray-Cot 1/2" x 1" Ref Number: 60-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: Lot Number 2015/09 BV 2015/11 BE 2015/12 AG 2015/12 AV 2015/12 AB

Lot Numbers:

numbers

Number

Product: American Surgical Ray-Cot 1/2" x 1.5" Ref Number: 60-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/11 AJ

Lot Numbers:

numbers

Product: American Surgical Ray-Cot 1/2" x 3" Ref Number: 60-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 AC 2015/09 BH 2015/10 AA 2015/10 BJ 2015/11 BC 2015/12 AU 2015/12 AK 2015/12 CK

Lot Numbers:

numbers

Product: American Surgical Ray-Cot 1" x 1" Ref Number: 60-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BB 2015/12 BM

Lot Numbers:

numbers

Product: American Surgical Ray-Cot 1" x 3" Ref Number: 60-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 CD 2015/09 CB 2015/10 AV 2015/12 BL

Lot Numbers:

numbers

Product: American Surgical Ray-Cot 3" x 3" Ref Number: 60-15 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/11 AT

Lot Numbers:

numbers

Product: American Surgical Ray-Cot 1.5" x 3" Ref Number: 60-22 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 BV 2015/10 CC 2015/12 CM

Lot Numbers:

numbers

Product: American Surgical Ray-Cot 1/2" x 2" Ref Number: 60-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 CS 2015/11 CD 2015/12 BJ

Lot Numbers:

numbers

Product: American Surgical Delicot 5 mm x 8 mm Ref Number: 63-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 CF 2015/09 CI 2015/10 CM 2015/11 AH 2015/10 CA 2015/11 AM 2015/11 BO 2015/12 AL 2015/11 BS 2015/11 BV 2015/11 BY 2015/12 AT 2015/12 BF 2015/12 CA

Lot Numbers:

numbers

Product: American Surgical Delicot non-xray 5 mm x 8 mm Ref Number: 63-01 Non X-Ray Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 BY 2015/10 CV

Lot Numbers:

numbers

Product: American Surgical Delicot-J 5 mm x 8 mm Ref Number: 63-01J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 BS

Lot Numbers:

numbers

Product: American Surgical Delicot 5 mm x 13 mm Ref Number: 63-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 CK 2015/10 BE 2015/10 CN 2015/11 AI 2015/12 AQ

Lot Numbers:

numbers

Product: American Surgical Delicot non-xray 5 mm x 13 mm Ref Number: 63-02 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10R CL

Lot Numbers:

numbers

Product: American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 CL 2015/09 BT 2015/10 BT 2015/11 BG 2015/12 AI 2015/12 CF 2015/12 CQ 2016/01 AK 2016/01 AA

Lot Numbers:

numbers

Product: American Surgical Delicot non-xray 10 mm x 13 mm Ref Number: 63-03 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 CB

Lot Numbers:

numbers

Product: American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AQ 2015/10 BC 2015/10 BW 2015/11 AK 2015/11 CJ 2015/12 AH 2015/12 CH

Lot Numbers:

numbers

Product: American Surgical Delicot-J 15 mm x 20 mm Ref Number: 63-04J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2016/01 AQ

Lot Numbers:

numbers

Product: American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AQ 2015/10 BC 2015/10 BW 2015/11 AK 2015/11 CJ 2015/12 AH 2015/12 CH

Lot Numbers:

numbers

Product: American Surgical Delicot 6 mm x 50 mm Ref Number: 63-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BC 2015/11 BB

Lot Numbers:

numbers

Product: American Surgical Delicot 9 mm x 50 mm Ref Number: 63-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: Lot Number 2015/08 CE 2015/10 AS 2015/11 BD 2015/10 BX 2015/12 BH 2015/12 BW 2015/12 CP 2015/12 DC

Lot Numbers:

numbers

Number

Product: American Surgical Delicot 13 mm x 60 mm Ref Number: 63-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 AK 2015/09 BS 2015/10 AY 2015/10 BO 2015/11 BF 2015/12 AC 2015/12 CI 2015/12 CS 2015/12 CX

Lot Numbers:

numbers

Product: American Surgical Delicot-J 13 mm x 60 mm Ref Number: 63-08J (Japan only) Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 BN

Lot Numbers:

numbers

Product: American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BK 2015/10 AZ 2015/10 CK 2015/10 CO 2015/10 CW 2015/11 BJ 2015/11 BR

Lot Numbers:

numbers

Product: American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 BZ 2015/10 AG 2015/09 AW 2015/10 CD 2015/11 AZ 2015/11 BT 2015/12 AY 2015/11 BH 2015/12 CO 2015/12 DD

Lot Numbers:

numbers

Product: American Surgical Delicot-J 30 mm x 70 mm Ref Number: 63-10J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 BH 2015/11 CC

Lot Numbers:

numbers

Product: American Surgical Delicot X 6 mm x 50 mm Ref Number: 63x06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 CG

Lot Numbers:

numbers

Product: American Surgical Delicot X 9 mm x 50 mm Ref Number: 63x07 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 CH

Lot Numbers:

numbers

Product: American Surgical Uniqcot 1/4" x 1/4" Ref Number: 67-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 CN 2015/10 AU

Lot Numbers:

numbers

Product: American Surgical Uniqcot 1/2" x 1/2" Ref Number: 67-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2016/01 AG

Lot Numbers:

numbers

Product: American Surgical Uniqcot 1/2" x 1.5" Ref Number: 67-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/12 CD

Lot Numbers:

numbers

Product: American Surgical Uniqcot 1/2" x 3" Ref Number: 67-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AN

Lot Numbers:

numbers

Product: American Surgical Uniqcot 1/2" x 2" Ref Number: 67-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BG

Lot Numbers:

numbers

Product: American Surgical Cylindrical Sponges-Strung 1/2" x 1.5" Ref Number: 70-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/11 AN

Lot Numbers:

numbers

Product: American Surgical Telfa 3/8" x 3" Ref Number: 80-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/12 AD

Lot Numbers:

numbers

Product: American Surgical Telfa 1/2" x 1/2" Ref Number: 80-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 BK

Lot Numbers:

numbers

Product: American Surgical Telfa 1/2" x 1.5" Ref Number: 80-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot number:2015/11 BP

Lot Numbers:

number

Product: American Surgical Telfa 1/2" x 3" Ref Number: 80-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 CC 2015/10 BL 2015/12 BI 2016/01 AP 2015/12 CZ

Lot Numbers:

numbers

Product: American Surgical Telfa 3/4" x 3" Ref Number: 80-11 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/12 AP

Lot Numbers:

numbers

Product: American Surgical Telfa 1" x 1" Ref Number: 80-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 CI 2015/12 CU

Lot Numbers:

numbers

Product: American Surgical Telfa 1" x 3" Ref Number: 80-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 BS 2015/12 AR

Lot Numbers:

numbers

Product: American Surgical Policot 1/4" x 1/4" Ref Number: 90-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BE

Lot Numbers:

numbers

Product: American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BI

Lot Numbers:

numbers

Product: American Surgical Policot 1/2" x 1.5" Ref Number: 90-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BA

Lot Numbers:

numbers

Product: American Surgical Policot 1/2" x 2" Ref Number: 90-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2016/01 AF

Lot Numbers:

numbers

Product: Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: Lot Number 2015/09 AI 2015/10 CR 2015/12 BV 2015/12 CV

Lot Numbers:

numbers

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 73734

Status: Resolved

Manufacturer: American Surgical Company

Manufactured In: United States

Units Affected: 91 products (351 boxes; 689 boxes; 54 cases; 262 boxes; 35 boxes; 78 boxes; 33 boxes; 103 boxes; 37 boxes; 4 boxes; 24 boxes; 15 boxes; 22 boxes; 35 boxes; 37 boxes; 114 cases; 11 boxes; 15 boxes; 41 Boxes; 22 boxes; 39 boxes; 1 box; 32 boxes; 23 boxes; 45 boxes; 33 boxes; 155 boxes; 2 boxes; 23 boxes; 6 boxes; 33 boxes; 27 boxes; 87 boxes; 13 boxes; 182 boxes; 70 units; 237 units; 25 units; 34 boxes; 10 boxes; 3 boxes; 7 boxes; 4 boxes; 165 boxes; 3 boxes; 266 boxes; 165 boxes; 28 boxes; 449 boxes; 102 boxes; 209 boxes; 16 boxes; 27 boxes; 38 boxes; 287 boxes; 24 boxes; 27 boxes; 97 boxes; 21 boxes; 442 boxes; 4 boxes; 99 boxes; 68 boxes; 99 units; 113 boxes; 315 boxes; 409 boxes; 33 boxes; 343 boxes; 338 boxes; 37 boxes; 3 boxes; 1 box; 39 boxes; 7 boxes; 4 cases; 15 cases; 3 boxes; 11 boxes; 11 boxes; 24 boxes; 4 boxes; 178 boxes; 7 boxes; 10 boxes; 57 boxes; 3 boxes; 5 boxes; 4 boxes; 2 boxes; 16 BOXES)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot Number:/ 2015/08 BH 2015/09 BP 2015/10 BM 2015/11 BL 2015/12 AX 2015/12 CR 2016/01 AN

Lot Numbers:

Number

Product: American Surgical Delicot 30mm x 70mm Ref: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot number: 2015/08 BH 2015/09 BP 2015/10 BM 2015/11 BL 2015/12 AX 2015/12 CR 2016/01 AN 2015/08 BZ 2015/10 AG 2015/09 AW 2015/10 CD 2015/11 AZ 2015/11 BT 2015/12 AY 2015/11 BH 2015/12 CO 2015/12 DD

Lot Numbers:

number

Product: American Surgical Americot Blue 1/4" x 1/4" Ref Number: 20-01S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot number: 2015/09 AB 2015/12 BS 2015/12 BN 2016/01 AC

Lot Numbers:

number

Product: American Surgical Americot Blue 1/2" x 1/2" Ref Number: 20-04S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 CM 2015/09 AJ 2015/10 BI 2015/11 AY 2015/12 CJ

Lot Numbers:

numbers

Product: American Surgical Americot Blue 1/2" x 1" Ref Number: 20-05S Product Usage: Neurosurgical and Nonneurosurgical Sponges Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AB

Lot Numbers:

numbers

Product: American Surgical Americot Blue 1/2" x 1.5" Ref Number: 20-06S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BR 2015/12 BO 2015/12 BU

Lot Numbers:

numbers

Product: American Surgical Americot Blue 1/2" x 3" Ref Number: 20-07S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/12 CG

Lot Numbers:

numbers

Product: American Surgical Americot Blue 1" x 3" Ref Number: 20-10S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AL 2015/11 BZ 2015/12 CC 2016/01 AB

Lot Numbers:

numbers

Product: American Surgical Americot Blue 3/8" x 3/4" Ref Number: 20-14S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 CU 2015/11 BK 2015/12 DB

Lot Numbers:

numbers

Product: American Surgical Americot Blue 1/8" x 1/8" Ref Number: 20-19S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2016/01 AD

Lot Numbers:

numbers

Product: American Surgical Americot Blue 3/8" x 3/8" Ref Number: 20-22S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AR 2015/11 BX

Lot Numbers:

numbers

Product: American Surgical Americot Blue 3/8" x 2" Ref Number: 20-26S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BJ

Lot Numbers:

numbers

Product: American Surgical Americot Blue 1/4" x 1.5" Ref Number: 20-30S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 BL

Lot Numbers:

numbers

Product: American Surgical Americot White 1.5 cm x 5.5 cm Ref Number: 20-31SW Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/11 AV 2015/12 BC

Lot Numbers:

numbers

Product: American Surgical Americot Blue 1/2" x 2" Ref Number: 20-32S Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 CO 2016/01 AH 2016/01 AE

Lot Numbers:

numbers

Product: American Surgical Ultracot 5 mm x 8 mm Ref Number: 23-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 CG 2015/09 CA

Lot Numbers:

numbers

Product: American Surgical Ultracot 5 mm x 8 mm (Glassine) Ref Number: 23-01G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AJ 2015/10 CP 2015/11 BM

Lot Numbers:

numbers

Product: American Surgical Ultracot 5 mm x 13 mm (Glassine) Ref Number: 23-02G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 AY 2015/11 AA 2015/12 BB

Lot Numbers:

numbers

Product: American Surgical Ultracot 10 mm x 13 mm (Glassine) Ref Number: 23-03G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AH 2015/10 CE 2015/11 AB

Lot Numbers:

numbers

Product: American Surgical Ultracot 15 mm x 20 mm Ref Number: 23-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/12 BP

Lot Numbers:

numbers

Product: American Surgical Ultracot 15 mm x 20 mm (Glassine) Ref Number: 23-04G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 CJ 2015/11 AC 2015/12 BQ

Lot Numbers:

numbers

Product: American Surgical Ultracot 6 mm x 50 mm Ref Number: 23-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 CT

Lot Numbers:

numbers

Product: American Surgical Ultracot 9 mm x 50 mm (Glassine) Ref Number: 23-07G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 CF 2015/12 AO

Lot Numbers:

numbers

Product: American Surgical Ultracot 13 mm x 60 mm Ref Number: 23-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AP

Lot Numbers:

numbers

Product: American Surgical Ultracot 13 mm x 60 mm (Glassine) Ref Number: 23-08G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AI 2015/11 AD 2015/11 BU

Lot Numbers:

numbers

Product: American Surgical Ultracot 20 mm x 60 mm Ref Number: 23-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 CJ

Lot Numbers:

numbers

Product: American Surgical Ultracot 20 mm x 60 mm (Glassine) Ref Number: 23-09G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 AZ 2015/10 AD 2015/10 BQ 2015/10 CQ 2015/11 AE

Lot Numbers:

numbers

Product: American Surgical Ultracot 30 mm x 70 mm Ref Number: 23-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/11 CG

Lot Numbers:

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Product: American Surgical Ultracot 30 mm x 70 mm (Glassine) Ref Number: 23-10G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AE 2015/10 BP

Lot Numbers:

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Product: American Surgical Ultracot 15 mm x 15 mm (Glassine) Ref Number: 23-12G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AF

Lot Numbers:

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Product: American Surgical Ultracot 30 mm x 90 mm (Glassine) Ref Number: 23-15G Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 BK

Lot Numbers:

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Product: American Surgical Ultracot 70 mm x 10090 mm Ref Number: 23-24 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BZ 2015/11 BA

Lot Numbers:

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Product: American Surgical Cotton Balls-Strung 1/4" Ref Number: 30-00 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 CM 2015/11 AO 2015/12 BR

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Product: American Surgical Cotton Balls-Strung 3/8" Ref Number: 30-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BN

Lot Numbers:

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Product: American Surgical Cotton Balls-Strung 1/2" Ref Number: 30-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BN

Lot Numbers:

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Product: American Surgical Cotton Balls-Strung 3/4" Ref Number: 30-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 AD 2015/11 AP 2015/12 CE 2015/12 DA

Lot Numbers:

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Product: American Surgical Cotton Balls-Strung 1" Ref Number: 30-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 AI 2015/09 AA 2015/09 CL 2015/10 AT 2015/11 CH 2015/12 CB 2015/12 AJ

Lot Numbers:

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Product: American Surgical Cotton Balls-Strung 1.25" Ref Number: 30-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 CK 2015/10 BF

Lot Numbers:

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Product: American Surgical Cotton Balls-Strung 1/8" Ref Number: 30-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: Lot Number 2015/11 AL 2015/12 AS 2015/12 BD 2015/12 DJ

Lot Numbers:

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Product: American Surgical Cotton Balls-Non-Strung 3/4" Ref Number: 31-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AO

Lot Numbers:

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Product: American Surgical Cotton Balls-Non-Strung 1" Ref Number: 31-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 BR

Lot Numbers:

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Product: American Surgical Cotton Balls-Non-Strung 1/8" Ref Number: 31-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/12 AW

Lot Numbers:

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Product: American Surgical Tonsil Sponges 1" Large Ref Number: 50-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/12 BE

Lot Numbers:

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Product: American Surgical Ray-Cot 1/4" x 1/4" Ref Number: 60-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 AX 2015/10 BU 2015/10 BZ 2015/11 BN 2015/12 BK 2015/12 AF 2015/12 CL

Lot Numbers:

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Product: American Surgical Ray-Cot 1/4" x 3" Ref Number: 60-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/12 AA

Lot Numbers:

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Product: American Surgical Ray-Cot 1/2" x 1/2" Ref Number: 60-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 AO 2015/09 BU 2015/11 BW 2015/12 BX 2015/12 DN

Lot Numbers:

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Product: American Surgical Ray-Cot 1/2" x 1" Ref Number: 60-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: Lot Number 2015/09 BV 2015/11 BE 2015/12 AG 2015/12 AV 2015/12 AB

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Product: American Surgical Ray-Cot 1/2" x 1.5" Ref Number: 60-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/11 AJ

Lot Numbers:

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Product: American Surgical Ray-Cot 1/2" x 3" Ref Number: 60-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 AC 2015/09 BH 2015/10 AA 2015/10 BJ 2015/11 BC 2015/12 AU 2015/12 AK 2015/12 CK

Lot Numbers:

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Product: American Surgical Ray-Cot 1" x 1" Ref Number: 60-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BB 2015/12 BM

Lot Numbers:

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Product: American Surgical Ray-Cot 1" x 3" Ref Number: 60-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 CD 2015/09 CB 2015/10 AV 2015/12 BL

Lot Numbers:

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Product: American Surgical Ray-Cot 3" x 3" Ref Number: 60-15 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/11 AT

Lot Numbers:

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Product: American Surgical Ray-Cot 1.5" x 3" Ref Number: 60-22 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 BV 2015/10 CC 2015/12 CM

Lot Numbers:

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Product: American Surgical Ray-Cot 1/2" x 2" Ref Number: 60-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 CS 2015/11 CD 2015/12 BJ

Lot Numbers:

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Product: American Surgical Delicot 5 mm x 8 mm Ref Number: 63-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 CF 2015/09 CI 2015/10 CM 2015/11 AH 2015/10 CA 2015/11 AM 2015/11 BO 2015/12 AL 2015/11 BS 2015/11 BV 2015/11 BY 2015/12 AT 2015/12 BF 2015/12 CA

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Product: American Surgical Delicot non-xray 5 mm x 8 mm Ref Number: 63-01 Non X-Ray Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 BY 2015/10 CV

Lot Numbers:

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Product: American Surgical Delicot-J 5 mm x 8 mm Ref Number: 63-01J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 BS

Lot Numbers:

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Product: American Surgical Delicot 5 mm x 13 mm Ref Number: 63-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 CK 2015/10 BE 2015/10 CN 2015/11 AI 2015/12 AQ

Lot Numbers:

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Product: American Surgical Delicot non-xray 5 mm x 13 mm Ref Number: 63-02 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10R CL

Lot Numbers:

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Product: American Surgical Delicot 10 mm x 13 mm Ref Number: 63-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 CL 2015/09 BT 2015/10 BT 2015/11 BG 2015/12 AI 2015/12 CF 2015/12 CQ 2016/01 AK 2016/01 AA

Lot Numbers:

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Product: American Surgical Delicot non-xray 10 mm x 13 mm Ref Number: 63-03 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 CB

Lot Numbers:

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Product: American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AQ 2015/10 BC 2015/10 BW 2015/11 AK 2015/11 CJ 2015/12 AH 2015/12 CH

Lot Numbers:

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Product: American Surgical Delicot-J 15 mm x 20 mm Ref Number: 63-04J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2016/01 AQ

Lot Numbers:

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Product: American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AQ 2015/10 BC 2015/10 BW 2015/11 AK 2015/11 CJ 2015/12 AH 2015/12 CH

Lot Numbers:

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Product: American Surgical Delicot 6 mm x 50 mm Ref Number: 63-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BC 2015/11 BB

Lot Numbers:

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Product: American Surgical Delicot 9 mm x 50 mm Ref Number: 63-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: Lot Number 2015/08 CE 2015/10 AS 2015/11 BD 2015/10 BX 2015/12 BH 2015/12 BW 2015/12 CP 2015/12 DC

Lot Numbers:

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Product: American Surgical Delicot 13 mm x 60 mm Ref Number: 63-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 AK 2015/09 BS 2015/10 AY 2015/10 BO 2015/11 BF 2015/12 AC 2015/12 CI 2015/12 CS 2015/12 CX

Lot Numbers:

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Product: American Surgical Delicot-J 13 mm x 60 mm Ref Number: 63-08J (Japan only) Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 BN

Lot Numbers:

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Product: American Surgical Delicot 20 mm x 60 mm Ref Number: 63-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BK 2015/10 AZ 2015/10 CK 2015/10 CO 2015/10 CW 2015/11 BJ 2015/11 BR

Lot Numbers:

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Product: American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 BZ 2015/10 AG 2015/09 AW 2015/10 CD 2015/11 AZ 2015/11 BT 2015/12 AY 2015/11 BH 2015/12 CO 2015/12 DD

Lot Numbers:

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Product: American Surgical Delicot-J 30 mm x 70 mm Ref Number: 63-10J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 BH 2015/11 CC

Lot Numbers:

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Product: American Surgical Delicot X 6 mm x 50 mm Ref Number: 63x06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 CG

Lot Numbers:

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Product: American Surgical Delicot X 9 mm x 50 mm Ref Number: 63x07 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 CH

Lot Numbers:

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Product: American Surgical Uniqcot 1/4" x 1/4" Ref Number: 67-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 CN 2015/10 AU

Lot Numbers:

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Product: American Surgical Uniqcot 1/2" x 1/2" Ref Number: 67-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2016/01 AG

Lot Numbers:

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Product: American Surgical Uniqcot 1/2" x 1.5" Ref Number: 67-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/12 CD

Lot Numbers:

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Product: American Surgical Uniqcot 1/2" x 3" Ref Number: 67-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/10 AN

Lot Numbers:

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Product: American Surgical Uniqcot 1/2" x 2" Ref Number: 67-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BG

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Product: American Surgical Cylindrical Sponges-Strung 1/2" x 1.5" Ref Number: 70-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/11 AN

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Product: American Surgical Telfa 3/8" x 3" Ref Number: 80-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/12 AD

Lot Numbers:

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Product: American Surgical Telfa 1/2" x 1/2" Ref Number: 80-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 BK

Lot Numbers:

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Product: American Surgical Telfa 1/2" x 1.5" Ref Number: 80-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot number:2015/11 BP

Lot Numbers:

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Product: American Surgical Telfa 1/2" x 3" Ref Number: 80-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 CC 2015/10 BL 2015/12 BI 2016/01 AP 2015/12 CZ

Lot Numbers:

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Product: American Surgical Telfa 3/4" x 3" Ref Number: 80-11 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/12 AP

Lot Numbers:

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Product: American Surgical Telfa 1" x 1" Ref Number: 80-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 CI 2015/12 CU

Lot Numbers:

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Product: American Surgical Telfa 1" x 3" Ref Number: 80-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/08 BS 2015/12 AR

Lot Numbers:

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Product: American Surgical Policot 1/4" x 1/4" Ref Number: 90-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BE

Lot Numbers:

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Product: American Surgical Policot 1/2" x 1/2" Ref Number: 90-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BI

Lot Numbers:

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Product: American Surgical Policot 1/2" x 1.5" Ref Number: 90-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2015/09 BA

Lot Numbers:

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Product: American Surgical Policot 1/2" x 2" Ref Number: 90-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: 2016/01 AF

Lot Numbers:

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Product: Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Lot numbers: Lot Number 2015/09 AI 2015/10 CR 2015/12 BV 2015/12 CV

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 73734

Status: Resolved

Manufacturer: American Surgical Company

Manufactured In: United States