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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Mckesson Medical-Surgical Inc. Corporate Office: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.; XXX

Agency Publication Date: August 26, 2022
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Affected Products

Product: MERIT MEDICAL SYSTEMS Temno Soft Tissue Biopsy Device Temno 14 Gauge 6 cm Length Beveled Sharp Tip Model Number: T146

GTIN: 00884450444467; 20884450444461; 10884450444464

Product: a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit Aspira Model Number: 4991503. b. MERIT MEDICAL SYSTEMS Aspira Pleural / Peritoneal Drainage Kit Aspira 1000 mL Sterile Model Number: 4992301.

GTIN: a. 00884450394984 (EA); 00801741045011 (EA); 10801741045018 (CA); 10884450394981 (CA); 20801741045015 (BX); 20884450394988 (BX). b. 00801741045035 (EA); 00884450394861 (EA); 10801741045032 (CA); 10884450394868 (CA); 20801741045039 (BX); 20884450394865 (BX)

Product: a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50 Tests-IVD. Part No. 0356-50. b. Coagulation Control Kit Coag-Sense PT / INR Test (Prothrombin Time Test) Low Level / High Level 10 Strips Part No. 03P69-10.

a. GTIN: 00861900000336; 10861900000395; 00861900000398. Lot codes distributed between 5/30/2021 - 8/24/2021. b. GTIN 00861900000343 Lots Distributed: 8/20/2021 - 8/20/2021

Lot Numbers:
codes
Product: Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 Mfg: FERROSAN MEDICAL DEVICES A/S Indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical.

GTIN: 15712123000288; 25712123000285 Lot 262801 Lots Distributed: 6/1/2021 - 6/2/2021

Lot Numbers:
262801
Product: HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid ABX Pentra Eching Solution CP For ABX Pentra 400 Clinical Chemistry Analyzer 25 mL. Ref: 1220001769

GTIN: 03610230005514 Lots Distributed:5/30/2021 - 6/9/2021

Product: a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General Chemistry Creatinine Model Number: 1220001933

GTIN: 03610230005736 Lots Distributed: 5/30/2021 - 9/8/2021

Product: a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum / Urine Sample 25 Tests. Model Number: 5002. b. McKesson Consult Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Urine Sample 25 Tests Model Number: 5000. c. McKesson Medical-Surgical McKesson TEST KIT, PREG HCG CASSETTE WAIVED Model Number: 5001

GTIN: 10612479218625; 20612479202768 all lots and expiration dates received during July 4th through September 30th, 2021. b. GTIN: 10612479218618; 20612479202751 All lots received between 7/4/21-9/30/21. c. GTIN: 10612479218601; 20612479202744

Product: Alere Toxicology TABLET, INSTANT BLUING F/DRUGSCREEN Model Number: 7875

GTIN: Unknown All lots received between 7/4/21-9/30/21

Product: Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug Fentanyl (FEN) Urine Sample 25 Tests. Model Number: AWFTY-114. b. Alere Drugs of Abuse Test E-Z Split Key Cup 12-Drug Panel AMP, BAR, BUP, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PPX, THC Urine Sample 25 Tests Model Number: DOA-1127-041-19. c. Instant Technologies, Inc. Drugs of Abuse Test iCup A.D. 5-Drug Panel with Adulterants AMP, COC, mAMP/MET, OPI, THC (OX, pH, SG) Urine Sample 25 Tests Model Number:

a. GTIN: Unknown All lots received between 7/4/21-9/30/21. b. GTIN:00815845020782; 10815845020789 All lots received between 7/4/21-9/30/21. c. GTIN:00858945006072; 10858945006079 All lots received between 7/4/21-9/30/21. d. GTIN: 00858945006133; 10858945006130 All lots received between 7/4/21-9/30/21. e. GTIN: 00817405020355; 00858945006829 All lots received between 7/4/21-9/30/21. f. GTIN: 00858945006508; 10858945006505 All lots received between 7/4/21-9/30/21. g. GTIN: 00817405020959 All lots received between 7/4/21-9/30/21. h. GTIN: 00816862020076; 10816862020073; 00816862029079; 00816862025071 All lots received between 7/4/21-9/30/21. i. GTIN: 00817405021192 All lots received between 7/4/21-9/30/21. j. GTIN: 00858998006104 All lots received between 7/4/21-9/30/21. k. GTIN: 00815845020720; 10815845020727 All lots received between 7/4/21-9/30/21. l. GTIN: 00815845020355; 10815845020352. m. GTIN: 00816862025415.

Product: a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution, Model Number: 65035820, Model Number: USSCupA-12BUP300. b. Alcon Contact Lens Solution Opti Free Replenish 4 oz. Solution Model Number: 00065035604 Model Number: USSCupA-12BUP300. c. Alcon Contact Lens Solution Opti Free Replenish 10 oz. Solution Model Number: 00065035610. d. Alcon Contact Lens Solution Opti Free Replenish 2 oz. Solution Model Number: 00065135658.

a. GTIN: 00047113609126 EA; 20300650358204 CS. All lots received between 7/4/21-9/30/21. b. GTIN: 00300650356350 EA; 20300650356354 CS All lots received between 7/4/21-9/30/21. c. GTIN: 00300650356107 EA; 20300650357207 CS All lots received between 7/4/21-9/30/21. d. GTIN: 00300651356380 EA, 20300650357399 CS All lots received between 7/4/21-9/30/21

Product: Perifix LOR Syringe Perifix 8 mL Pouch Luer Lock Tip Without Safety Model Number: 332152

GTIN: 04046964177613; 04046964177620

Product: B. Braun EVA Gravity Mixing Container 1000 mL Model Number: 2112363

GTIN: 04046964244926; 04046964244940; 04046964244933

Product: Ultracell Eye Pledget Ultracell 2 X 6 X 1 mm, Sterile Model Number: 40825

GTIN: 00886158012108; 30886158012109

Product: Wetfield Eraser Bipolar Hemostatic Eraser Wet-Field Eraser 23 Gauge Tapered Model Number: 221265

GTIN: 00886158010524; 30886158010525

Product: Cadwell Disposable Ground Electrodes Grounding Pad 1.25 X 1.75 Inch Dimensions, Disposable Model Number: 302288-000

GTIN: 20840067101395; 10840067101398; 00840067101391

Product: Excelsior Heparin Sodium, Porcine, Preservative Free 100 U / mL Solution Prefilled Syringe, Partial Fill 5 mL Fill in 10 mL Syringe Model Number: 513604

GTIN: 00363807600515; 10363807600055; 00363807600058

Product: MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test Kit LeadCare II General Chemistry Blood Lead Test Whole Blood Sample 48 Tests Model Number: 70-6762

GTIN: 00850355006000

Product: Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult Infectious Disease Immunoassay Strep A Test Throat / Tonsil Saliva Sample 25 Tests, Model Number: 5003. b. QUIDEL Sofia TEST KIT, STREP A+ SOFIA (25/KT 12KT/CS) Model Number: 20274. c. Alere SAN DIEGO INC McKesson TEST, KIT STREP A DIPSTICK WAIVED (50/KT) Exempt Catalog #4999. d. In-Line Control Swab Quickvue In-Line Strep A Test Positive Level / Negative Level 12 Swabs (IVD) Catalog # 00345. e. (adde

GTIN: a. 00612479240100; 00612479202733. b. 30014613202745. c. 00612479202726; 612479240094. d. 30014613003458. e. 10815845020031, 00815845020034.

Product: a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening Fecal Occult Blood Test (iFOB or FIT) Stool Sample 25 Tests, Model Number: 4487. b. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit McKesson Consult Colorectal Cancer Screening Fecal Occult Blood Test (FOBT) Stool Sample 100 Tests Model Number: 4487. c. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit McKesson Consult Colorectal Cancer Screening Fecal Occult Blood Test (FOBT) Stool Sample 50 Tests Model Numbe

GTIN: a. 10612479219417; 20612479198368. b. 10612479226132; 20612479225569. c. 10612479226125; 20612479225552

Product: NANOSONICS LTD Sonex-HL Ultrasound Probe Disinfectant trophon Sonex-HL 80 mL Bottle For Trophon EPR Disinfection System Model Number: N00037

GTIN: 09350855000061; 09350855000078; 09350855000023

Product: Palmero Healthcare, LLC DisCide Ultra Surface Disinfectant Cleaner Quaternary Based Manual Pour Liquid 1 gal. Jug Herbal Scent NonSterile Model Number: 3565G

GTIN: 00840415100212

Product: TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Model Number:CDC-45703-XP1A (Model Numbers # IPN035619, IPN036437, IPN922677)

GTIN: 30801902058615; 00801902058614; 20801902058618;

Product: STERIS CORP Revital-Ox Resert Hydrogen Peroxide High-Level Disinfectant Revital-Ox RESERT RTU Liquid 4 Liter Container Max 21 Day Reuse Model Number: 4455AW

GTIN: 00724995095017; 50724995095012

Product: a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy Test Urine Sample 50 Tests Model Number: 92211.

GTIN: a. 10815845020130; 00815845020133. b. 10815845020093, 00815845020096

Product: GETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100 mL Model Number: 2002-000

GTIN: 00650862100013; 20650862100017

Product: 3M COMPANY 3M PAD, GROUNDING SAFETY RING Model Number: 9165

GTIN: 50707387462593; 00707387462598 EA

Product: MEDLINE INDUSTRIES Medline Catheter Insertion Tray Medline Foley Without Catheter Without Balloon Model Number: DYND10160

GTIN: 10080196997091; 40080196997092

Product: MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, with Cover Model Number: DYND12200

GTIN: 10080196030873; 40080196030874

Product: MEDLINE INDUSTRIES Centurion IV Securement Kit Model Number: IVSSTK3

GTIN: 10653160244950 EA; 00653160244953 CS

Product: Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) Model Number: 900-157

GTIN: 00888937003765; 20888937003769

Product: Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610

GTIN: a. 20612479161539; 30612479162472 BX; 40612479161571 CS. b. 20612479161546; 30612479162489 BX; 40612479161588 CS

Product: a. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number: 68-102800. b. METREX RESEARCH McKesson 14-Day Glutaraldehyde Solution DISINFECTANT, GLUTARALDEHYDE 14DAY (4GL/CS) MGM68 Model Number: 68-101400. c. METREX RESEARCH McKesson SOLUTION, GLUT 2.5% 28DAY QT (16/CS) PSS744 Catalog # 341. d. METREX RESEARCH LLC MetriCide DISINFECTANT, METRICIDE 14DAYGLUTARALDEHYDE 1GL (4/CS) Catalog # 10-1400. e. METREX RESEARCH LLC MetriCide28 DISINFECTANT, METRICIDE GLUT LN

GTIN: a. 10612479150581; 40612479150599 CS. b. 10612479150567; 40612479150575 CS. c. 10612479204406; 40612479204414. d. 00615375005453; 10615375005450 CS; H9711014002. e. 00615375005477; 10615375005474 CS; H97110280022

Product: MedSource IV Start kit, 8inch Extension Set IV START KIT, W/SITE LOC/8" EX100/CS Model Number: MS-80047

GTIN: 00816703021811

Product: B. BRAUN MEDICAL INC. Anesthesia Support Tray SUPPORT TRAY, +EXT SET(10/CS)ST200E Model Number: 332116

GTIN: 04046964177538; 04046964177545

Product: a. BECTON DICKINSON BD Vacutainer C&S Preservative Urine Tube TUBE, URINE COLL PLAS 4ML (100/BX 10BX/CS), Model Number: BD 364951. b. BECTON DICKINSON BD Vacutainer C&S Transfer Straw Kit TRANSFER STRAW KIT, URINE 4ML(50/BX 4BX/CS) Model Number: BD 364953. c. BECTON DICKINSON BD Vacutainer COLLECTION KIT, URINE COMPLETE 8ML 13"X75" (50/CS) BD Model Number: 364957

GTIN: a. 00382903649518 EA; 30382903649519 PK; 50382903649513. b. 00382903649532; 30382903649533; 50382903649537. c. 00382903649570 EA; 50382903649575 CS

Product: a. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 3.5ML PLAS VACUTAINER (100/BX), Model Number: 367983. b. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP RED/GRY8.5ML PLAS VACUTAINER (100/BX Model Number: 367988. c. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 5MLPLAS VACUTAINER (100/BX) Model Number: 367986. d. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP RED/GRY7.5ML PLAS VACUTAINER (100/BX) Model Number: 367987. e. BECTO

GTIN: a. 00382903679836; 50382903679831. b. 00382903679881; 50382903679886. c. 00382903679867; 50382903679862. d. 00382903679874; 50382903679879, e. 00382903679812; 50382903679817. f. 00382903664306; 30382903664307; 50382903664301. g. 00382903659784; 50382903659789. h. 00382903627615; 50382903627610. i. 00382903687749; 50382903687744. j. 00382903630837; 50382903630832.

Product: a. Medefil Normal Saline IV Flush Syringe NORMAL SALINE FLUSH, SYR 10ML/12ML (60/BX 16BX/CS), Model Number: MIS-1130. b. MEDEFIL INC McKesson SALINE IV FLUSH, SYR NORMAL 10ML/12ML .9% (60/BX 16BX/CS) Model Number: 191-MIS-1130.

GTIN: a. 10364253111300; 50364253000305; 30364253111304. b. 10612479247670; 40612479247695; 20612479247684.

Product: a. METREX RESEARCH CORP CaviCide1 DISINFECTANT, CLNR CAVICIDE1 1GL (4/CS) METREX, Model Number: 13-5000. b. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE 8OZ SPRAY MX-1008 METREX Model Number: 13-1008. c. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE GL MX-1000 METREX Catalog #13-1000. d. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE PUMP SPRAY 24OZ METREX Catalog #13-1024. e. CaviCide1 DISINFECTANT, CLNR CAVICIDE1 24OZ (12/CS) METREX Catalog #13-5024. f.

GTIN: a. 00615375005446; H97113500020. b. 00615375005309; H97113100824. c. 00615375005385; H9711310002. d. 00615375005361, H97113102422. e. 00615375005415, H97113502426. f. 00615375005354; H97113332427. g. 00615375005378; H113330021

Product: METREX RESEARCH CORP SPONGE, METRISPONGE W/METRIZYME (25/BX 4BX/CS) Model Number: 10-4025

GTIN: 00615375006771; 00615375003671

Product: Dynarex¿ PAD, NAIL POLISH REMOVER (100/BX 10BX/CS) DYNREX Catalog # 1501

GTIN: Not Available

Product: a. DERMA SCIENCES, INC. NG Strip FASTENER, NASAL TUBE IND WRAP(25/BX), Catalog NG25. b. DERMA SCIENCES, INC. Surgitube BANDAGE, GAUZE #2P 7/8"X50YDS DERSCI Catalog GL-242. c. DERMA SCIENCES, INC. Surgilast TUBE NET SZ3 MED 10YDS/EA HAND, ARM, LEG, FOOT SURGILAST Catalog # GL103. d. DERMA SCIENCES, INC. Surgitube & Surgigrip APPLICATOR, SURGITUBE/GRIP METAL SZ3 6" CHLD/ADLT DERSCI Catalog #GL-234.

a. GTIN: 00753567101252; 10753567101259. b. GTIN: 809958001158. c. GTIN: Not Available. d. GTIN: unknown

Product: FISHER SCIENTIFIC Sure-Vue PIPETTE, RPR DISPENSING (500/PK) Catalog # 23038015

Not Available

Product: BEAVER-VISITEC INTERNATIONAL, INC. Ultracell WICK, FENSTD PED 7MMX20MM(10/BX) BVRVIS Catalog #30316-C

Not Available

Product: BEAVER-VISITEC INTERNATIONAL, INC. Visitec CANNULA, LASIK IRR (10/BX)BVRVIS Catalog #585278

GTIN: 30886158002995; 00886158002994 EA

Product: FISHER SCIENTIFIC Fisherbrand SWAB TRANS STUARTS DBL 50BX Catalog #1490721

Unknown

Product: FISHER SCIENTIFIC Aseptic Control¿ LUBRICATING JELLY PAP TEST 4OZ(12/PK) Catalog #22998006

Not available

Product: BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog #628020. b. COULTER DxH Cleaner REAGENT, CLEANER FP DXH 10LCOULTR Catalog #628023. c. DxH 500 Series Lyse LYSE, VERSA SOL DXH 500 SERIES(0.5L/KT) Catalog # B36846. d. DxH 500 Series Cleaner CLEANER, COULTER CLENZ DXH 500SERIES (0.5L/KT) Catalog # B36868

GTIN: a. 15099590233716. b. 15099590233747. c. 15099590671860. d. 15099590671877

Product: CENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS) CNTURN Catalog # CKF105L

GTIN: 00653160044300, 50653160044305

Product: COOPER SURGICAL Milex PESSARY, RING MILEX INCONT FLEXIBLE SZ6 1 3/4" Catalog # MXPCON06

GTIN: 888937004427

Product: MORRISON MEDICAL Morrison Medical OB KIT, HARD PK SEALED W/CARDBOARD BX MORMED Catalog #0967NL

GTIN: 00647921096707

Product: DYNAREX Dynarex SWABSTICK, PVP (3/PK 25/BX 10BX/CS) Catalog #1202

GTIN: Not available

Product: Dynarex SWAB, LEMON GLYCERIN (3/PK 25PK/BX 10BX/CS) DYNREX Catalog # 1216

GTIN: Not available

Product: DYNAREX DynaLube LUBRICATING JELLY, STR 2.7GM (144/BX 12BX/CS) Catalog #1250

GTIN: 00616784125039; 00616784125015; '00616784125022

Product: FISHER SCIENTIFIC Fisherbrand SWAB, ROUND BOTTOM CLR (50/PK)FSHSCI Catalog # 1490712

GTIN: Unknown

Product: MEDICAL CHEMICAL CORPORATION Total-Fix STOOL COLL KIT, TOTAL FIX PARASITOLOGY (100/CS) Catalog # NC0585129

GTIN: Unknown

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90336
Status: Active
Manufacturer: Mckesson Medical-Surgical Inc. Corporate Office
Manufactured In: United States
Units Affected: 54 products (a. 27 boxes b. 1 box; 2 cases; 3 each; a. 28 b. 22; a. 108 b. 838 c. 1225; 1 Btl; a. unk b. 6 c. 1 d. 1 e. 67 f. 1 g. 10 h. 51 i. 27 j. 105 k. 4 l. 2 m. 3; a. 3 b. 91 c. 45 d. 2; 415 eaches; 1 Case; 2 Box; 1 box; 2 Boxes; 13 boxes; 81 kits; a. 214 kits b. 1cs c. 53 kits d. 4 bx e. 1 KT; a. 123 b. 407; 8 Boxes; boxes: a. 20 b. 21 c. 4; 31 Boxes; 8 Eaches; 5 each; 20.25 CS; a. 5 kits b. 12 kits; 6 each; 8 cases; 60 each; 1 Case; 3 cases; 5 each; a. 30 each b. 0.3 cs; 28 gallons b. 38 gal c. 16 qt d. 40 gal e. 124 gal; 53 each; 16 cases; a. 25 bx b. 53 bx c. 31 cs; a. 67 boxes b. 131 c. 51 d. 121 e. 2 f. 38 g. 16 h. 240 i. 17 j. 41; a. 20 Boxes b. 1 bx; 50cs b. 38 c. 519gal d. 1671 e. 43.25cs f. 33btl g. unk; 5 Boxes; 2 Boxes; a. 772 b. 9 c. 1 d. 1; 3 pk; 3 Boxes; 1 Box; 25 Boxes; 7 packs; a. 11 b. 13 c. 15 d. 33; 1 each; 16 each; 197 boxes; 135.08 boxes; 17.5 boxes; 154 pack; 1 case)
Agency Last Updated: November 30, 2022

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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.