Z-1095-2024 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
- 385028 units
Product Description
MEDLINE Kits, trays, and packs labeled as follows: a) CATH LAB CDS, REF CDS840228F; b) PEDIATRIC PORT A CATH TRAY, REF DYNDC2128B; c) PK, RADIOLOGY, REF DYNJ44087A; d) PORT ACCESS PACK-LF, REF DYNJ0352159C; DYNJ0352159D
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 CDS840228F, UDI/DI 40889942778547 (case), 10889942778546 (unit), Lot Numbers: 22CLA155, 22FLA788, 22GLA774, 22KLB047, 23CLA672, 23CLA832, 23ELA032, 23FLA055, 23FLA663; b) REF DYNDC2128B, UDI/DI 40195327249114 (case), 10195327249113 (unit), Lot Numbers: 22IBG388; c) REF DYNJ44087A, UDI/DI 40889942561804 (case), 10889942561803 (unit), Lot Numbers: 21112457, 22022812, 22022812, 22022812, 22094063, 22104208, 22032993, 21112457, 22104208; d) REF DYNJ0352159C, UDI/DI 40889942622581 (case), 10889942622580 (unit), Lot Numbers: 22FBH338, 22OBE815; REF DYNJ0352159D, UDI/DI 40195327196616 (case), 10195327196615 (unit), Lot Numbers: 23AME808, 23EMI159, 23FME004, 23JMJ796