Recall Z-1173-2025— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2025-01-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit. 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..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-03
- Firm location
- Northfield, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.