MEDLINE Kits, trays, and packs labeled as follows: a) Description, REF DYNDH1679; b) BREAST BIOPSY TRAY, REF DYNDH1664; c) BREAST BIOPSY TRAY, REF DYNDH1431A; d) BREAST BIOPSY TRAY, REF DYNJ46448; e) BREAST BIOPSY TRAY, REF DYKE1520B; f) COLON KIT- BERLIN, REF DYNDH1808;

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    a) REF DYNDH1679, UDI/DI 40653160991534 (case), 10195327007041 (unit), Lot Numbers: DYNDH1431A; b) REF DYNDH1664, UDI/DI 40193489993930 (case), 10193489993929 (unit), Lot Numbers: DYNDH1664; c) REF DYNDH1431A, UDI/DI 40889942880486 (case), 10889942880485 (unit), Lot Numbers: DYNDH1679; d) REF DYNJ46448, UDI/DI 40888277261465 (case), 10888277261464 (unit), Lot Numbers: 23ADA841; e) REF DYKE1520B, UDI/DI 40193489374958 (case), 10193489374957 (unit), Lot Numbers: 22ABB336, 22EBF090, 22FBF262, 22GBI072, 22HBE089, 22JBW122, 22OBH222, 23ABI623, 23BBL273, 23DBF391, 23FBJ442; f) REF DYNDH1808, UDI/DI 40195327264308 (case), 10195327264307 (unit), Lot Numbers: DYNDH1808, DYNDH1808, DYNDH1808
  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 Kits, trays, and packs labeled as follows: a) Description, REF DYNDH1679; b) BREAST BIOPSY TRAY, REF DYNDH1664; c) BREAST BIOPSY TRAY, REF DYNDH1431A; d) BREAST BIOPSY TRAY, REF DYNJ46448; e) BREAST BIOPSY TRAY, REF DYKE1520B; f) COLON KIT- BERLIN, REF DYNDH1808;

Product Codes/Lot Numbers:

a) REF DYNDH1679, UDI/DI 40653160991534 (case), 10195327007041 (unit), Lot Numbers: DYNDH1431A; b) REF DYNDH1664, UDI/DI 40193489993930 (case), 10193489993929 (unit), Lot Numbers: DYNDH1664; c) REF DYNDH1431A, UDI/DI 40889942880486 (case), 10889942880485 (unit), Lot Numbers: DYNDH1679; d) REF DYNJ46448, UDI/DI 40888277261465 (case), 10888277261464 (unit), Lot Numbers: 23ADA841; e) REF DYKE1520B, UDI/DI 40193489374958 (case), 10193489374957 (unit), Lot Numbers: 22ABB336, 22EBF090, 22FBF262, 22GBI072, 22HBE089, 22JBW122, 22OBH222, 23ABI623, 23BBL273, 23DBF391, 23FBJ442; f) REF DYNDH1808, UDI/DI 40195327264308 (case), 10195327264307 (unit), Lot Numbers: DYNDH1808, DYNDH1808, DYNDH1808

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1098-2024

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