PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: February 26, 2025 Initiated: January 3, 2025 #Z-1173-2025

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.

Details

Units Affected
36 units
Distribution
US: CA
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 36 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 26, 2025. Severity: Moderate. Recall number: Z-1173-2025.