FDA recall Z-1173-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

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.

Distribution

US: CA

Key facts

Status: Ongoing
Initiation date: 2025-01-03
Report date: 2025-02-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1173-2025