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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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Critical RiskFDA Device
Medical Devices/Surgical Equipment

MEDLINE INDUSTRIES, LP - Northfield: Medical Kits and Trays Recalled for Possible Lack of Sterility

Agency Publication Date: February 25, 2024
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Summary

Medline Industries is recalling more than 6.2 million Medline and Centurion brand kits and trays because they contain saline or sterile water components that may not be sterile. The solutions were manufactured by Nurse Assist, which issued a recall for specific lots of 0.9% Sodium Chloride Irrigation and Sterile Water for Irrigation due to sterility concerns. These kits are used in a wide variety of medical settings for procedures like tracheostomy care, catheterization, and wound irrigation. Consumers and healthcare providers should contact their healthcare provider or Medline for guidance on returning these devices.

Risk

A lack of sterility in medical solutions can introduce harmful bacteria or other microorganisms directly into a patient’s body during medical procedures. This creates a critical risk of serious infection, especially when used in invasive procedures such as inserting catheters or cleaning surgical sites. No specific injuries have been reported in this notice.

What You Should Do

  1. Identify affected products by checking the REF (reference) number and lot number on the outer packaging. Look for brand names Medline or Centurion.
  2. Check your inventory for specific REF numbers such as DYND40511, DYNDJ1129, TC7170, DYNDA1482, and ART995 among hundreds of other procedure-specific kits.
  3. Verify the lot numbers on your packaging against the extensive list of affected codes, which include numbers like 22DBO136, 23EBD895, 2022040690, and 23CMB869.
  4. If you find an affected kit, stop using it immediately and place it in a secure area to ensure it is not used for any medical procedures.
  5. Contact Medline Industries directly at 1-800-MEDLINE (1-800-633-5463) or via their website at www.medline.com for instructions on returning the product and obtaining replacements.
  6. If you have used one of these kits recently and are experiencing unusual symptoms or signs of infection, contact your doctor or healthcare provider immediately.
  7. For additional information, contact the FDA at 1-888-463-6332.

Your Remedy Options

📋Other Action

Healthcare provider consultation and manufacturer contact

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: MEDLINE TRAY TRACH BASIC SOLUTION
Model / REF:
DYND40511
UPC Codes:
40888277597922
10888277597921
Lot Numbers:
22DBO136
22EBE146
22HBP422
22IBN508
22IBS920
22KBS241
23BBE594
23CBN979
23EBT594
23IBA884
Product: STOMA & TRACH CLEANING KIT
Model / REF:
DYNDJ1129
UPC Codes:
40195327391400
10195327391409
Lot Numbers:
23EBD895
23EBD896
23EBD897
23GBQ880
Product: TRACH CARE TRAY
Model / REF:
DYNDJ1057A
UPC Codes:
40888277204790
10888277204799
Lot Numbers:
23ABA019
23EBM580
23HBU078
23DBC974
Product: TRACHEOSTOMY CARE KIT
Model / REF:
DYNDA1893A
UPC Codes:
40193489866125
10193489866124
Lot Numbers:
23CBA077
23CBI537
23CBT627
23DBF373
23EBM582
23HBV368
23JBP946
Product: TRACH CARE TRAY
Model / REF:
DYNDA1482
UPC Codes:
40889942131151
10889942131150
Lot Numbers:
2022040690
2022052390
2022102090
2023011790
Product: SUCTION CATH 10FR KIT W/SALINE
Model / REF:
DYND41470SA
DYND41470SAH
UPC Codes:
40884389338705
10884389338704
Lot Numbers:
22HBD360
22IBA256
23ABU349
23CBG160
23GBV051
23IBT355
Product: TRACH CARE TRAY
Model / REF:
DYNDA1931B
DYNDA1931BH
UPC Codes:
40195327277360
10195327277369
Lot Numbers:
22LMC118
22LMC126
23EMB086
Product: MEDLINE BRONCHOSCOPY TRAY
Model / REF:
DYNDL1350A
DYNDL1350AH
UPC Codes:
40889942880486
10889942880485
Lot Numbers:
2022022550
2022050550
2022051050
22GBH314
23ABI645
23BBL282
23BBU137
23EBM149
23FBC531
23GBJ019
23HBD916
Product: MEDLINE ARTERIAL BUNDLE NO CATHETER
Model / REF:
ART995
UPC Codes:
20193489190509
10193489190502
Lot Numbers:
2022050650
Product: CATH LAB CDS
Model / REF:
CDS840228F
UPC Codes:
40889942778547
10889942778546
Lot Numbers:
22CLA155
22FLA788
22GLA774
22KLB047
23CLA672
23CLA832
23ELA032
23FLA055
23FLA663
Product: PEDIATRIC PORT A CATH TRAY
Model / REF:
DYNDC2128B
UPC Codes:
40195327249114
10195327249113
Lot Numbers:
22IBG388
Product: PK, RADIOLOGY
Model / REF:
DYNJ44087A
UPC Codes:
40889942561804
10889942561803
Lot Numbers:
21112457
22022812
22094063
22104208
22032993
Product: PORT ACCESS PACK-LF
Model / REF:
DYNJ0352159C
DYNJ0352159D
UPC Codes:
40889942622581
10889942622580
40195327196616
10195327196615
40195327056125
10195327056124
Lot Numbers:
22FBH338
22OBE815
23AME808
23EMI159
23FME004
23JMJ796
23AME774
Product: DIALYSIS FISTULA KIT
Model / REF:
DYNDC3106
UPC Codes:
40193489913270
10193489913279
Lot Numbers:
21LBT706
22CBE273
Product: ENDO KIT
Model / REF:
DYKE1346D
UPC Codes:
40195327114085
10195327114084
Lot Numbers:
22GBO510
23BBG861
23CBM313
23EBN617
23FBU655
23GBR877
23IBH963
Product: MAINTENANCE FLUSH KIT/BLOOD DRAW
Model / REF:
DT19335A
UPC Codes:
00653160348477
10653160348474
Lot Numbers:
2022031480
2022041180
Product: SERUM TEAR KIT
Model / REF:
DYNDA1545
UPC Codes:
40889942214885
10889942214884
Lot Numbers:
22FMC728
23CMB090
Product: ENT/EPISTAXIS TRAY
Model / REF:
MNS2895
MNS2895H
UPC Codes:
50653160062934
653160062939
Lot Numbers:
23BBQ180
23DBN766
23EBH195
23FBE540
Product: LATEX FREE TRACHEOSTOMY CARE TRAY
Model / REF:
TC7170
UPC Codes:
50653160043629
00653160043624
Lot Numbers:
2022042790
2022121290
2023031790
2023042490
2023092190
Product: WOUND CARE TRAY - LATEX-FREE
Model / REF:
DYND06002
UPC Codes:
40080196816645
10080196816644
Lot Numbers:
2022041290
2022051090
2022062090
2022081190
2022081790
2022101990
2022102090
2022111490
2023050390
2023050890
2023042890
2023050490
2023063090
2023062990
2023070390
2023072890
2023082590

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93800
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Hospitals; Healthcare facilities; Medical distributors
Manufactured In: United States
Units Affected: 40 products (385028 trays; 2683387 units; 385028 units; 385028 units; 3297 units; 5969 units; 18 units; 35 units; 1184 units; 10391 units; 228 units; 139 units; 2205 units; 26171 units; 21154 units; 3900 units; 16 units; 1270 units; 86699 units; 12000 units; 991,744 units; 72,624 units; 844 units; 2903 units; 533 units; 483 units; 279 units; 5724 units; 14280 units; 1,012,700 units; 220 units; 10391 units; 60 units; 14234 units; 528 units; 11812 units; 576 units; 113249 units; 120 units; 1260 units)
Distributed To: Nationwide

Were You Affected by This Recall?

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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.