Z-1173-2025 Class II Ongoing
FDA device recall Z-1173-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on January 3, 2025 and is designated Class II. Reason for recall: 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 d… The recall status is ongoing. Affected quantity: 36 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2025
- Initiation Date
- January 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 units
Product Description
Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
Reason for Recall
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.
Distribution Pattern
US: CA
Code Information
UDI/DI 10193489736755 (ea) 40193489736756 (cs), Lot Numbers: 22HLA247, 21HLA443, 21JLA520, 22GLA335.