Z-1115-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 6, 2024
- Initiation Date
- November 15, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYNDH1641A; c) LCPH LAB DRAW KIT, REF DYNDH1641AH; d) OB LAB COLLECTION KIT, REF DYNDH1719A;
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.
Distribution Pattern
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Code Information
a) REF DYNDV2183A, UDI/DI 40195327050710 (case), 10195327050719 (unit), Lot Numbers: 22ABT635, 22ABY152, 22BBO850; b) REF DYNDH1641A, UDI/DI 40195327003273 (case), 10195327006839 (unit), Lot Numbers: 22DMB468; c) REF DYNDH1641AH, UDI/DI 40195327003273 (case), 10195327006839 (unit), Lot Numbers: 22DMB468; d) REF DYNDH1719A, UDI/DI40889942880486 (case), 10889942880485 (unit), Lot Numbers: 23ABC589, 23ABR972, 23BBS014