Device product
Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
Z-1173-2025
Product summary
- Event
- Event 96163
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 36 units
- Official record key
device-enforcement:Z-1173-2025
Official wording
Reason: Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potential sterility issue detected during testing.
Code information: UDI/DI 10193489736755 (ea) 40193489736756 (cs), Lot Numbers: 22HLA247, 21HLA443, 21JLA520, 22GLA335.
Distribution pattern: US: CA
Derived failure modes
-
Unknown
Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potential sterility issue detected during testing.