FDA Medical devices recall ·
Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397 recall
- Recall number
- Z-1173-2025
- Date
- (initiated January 3, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 36 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 10193489736755 (ea) 40193489736756 (cs), Lot Numbers: 22HLA247, 21HLA443, 21JLA520, 22GLA335.
Distribution
US: CA
States: California
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1173-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.