Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
This recall is currently active, issued February 14, 2025. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- January 3, 2025
- Posted
- February 14, 2025
- Recall Number
- Z-1173-2025
- Quantity
- 36 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
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
US: CA
Lot / Code Info
UDI/DI 10193489736755 (ea) 40193489736756 (cs), Lot Numbers: 22HLA247, 21HLA443, 21JLA520, 22GLA335.
Root Cause
Packaging
Action Taken
Medline issued an URGENT MEDICAL DEVICE RECALL on 01/03/2025 via email and US Mail, first class. The notice explained the issue, the low probability of clinical risk, and requested the consignee perform the following actions: identify and quarantine all affected product and respond to the notice using the website. Those consignees with affected product will receive labels to affix to the package stating not to use the affected component. All those who further distributed or transferred the product were directed to notify those to whom the product was distributed..