MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, REF DYNDJ1129; b) TRACH CARE TRAY, REF DYNDJ1057A; c) TRACHEOSTOMY CARE KIT, REF DYNDA1893A; d) TRACH CARE TRAY, REF DYNDA1482

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    a) REF DYNDJ1129, UDI/DI 40195327391400 (case), 10195327391409 (unit), Lot Numbers: 23EBD895, 23EBD896, 23EBD897, 23GBQ880; b) REF DYNDJ1057A, UDI/DI 40888277204790 (case), 10888277204799 (unit), Lot Numbers: 23ABA019, 23EBM580, 23HBU078; c) REF DYNDA1893A, UDI/DI 40193489866125 (case), 10193489866124 (unit), Lot Numbers: 23CBA077, 23CBI537, 23CBT627, 23DBF373, 23EBM582, 23HBV368, 23JBP946; d) REF DYNDA1482, UDI/DI 40889942131151 (case), 10889942131150 (unit), Lot Numbers: 2022040690, 2022052390, 2022102090, 2023011790
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
MEDLINE INDUSTRIES, LP - Northfield
Reason for Recall:
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, REF DYNDJ1129; b) TRACH CARE TRAY, REF DYNDJ1057A; c) TRACHEOSTOMY CARE KIT, REF DYNDA1893A; d) TRACH CARE TRAY, REF DYNDA1482

Product Codes/Lot Numbers:

a) REF DYNDJ1129, UDI/DI 40195327391400 (case), 10195327391409 (unit), Lot Numbers: 23EBD895, 23EBD896, 23EBD897, 23GBQ880; b) REF DYNDJ1057A, UDI/DI 40888277204790 (case), 10888277204799 (unit), Lot Numbers: 23ABA019, 23EBM580, 23HBU078; c) REF DYNDA1893A, UDI/DI 40193489866125 (case), 10193489866124 (unit), Lot Numbers: 23CBA077, 23CBI537, 23CBT627, 23DBF373, 23EBM582, 23HBV368, 23JBP946; d) REF DYNDA1482, UDI/DI 40889942131151 (case), 10889942131150 (unit), Lot Numbers: 2022040690, 2022052390, 2022102090, 2023011790

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1091-2024

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