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Open, Classified

Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit

FDA Recall Z-1173-2025 · Posted 2025-02-14

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2025-01-03
Product Quantity36 units

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.

Firm Action

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..

Root Cause

Packaging

Distribution Pattern

US: CA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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