MEDLINE INDUSTRIES, LP - Northfield: Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R

Hazard

Devices may have higher than expected amounts of bacterial endotoxin.

Details from the source

Reason for recall: Devices may have higher than expected amounts of bacterial endotoxin. Distribution: US Nationwide distribution in the states of AR, AZ, CA, CO, IA, IL, KS, OR, TN, TX, WA, and WI. Quantity: 74 units Lot/code info: 401582R UDI-DI: 10888277407510 (each) 20888277407517 (case), Lot Number: EP240528; 401904R UDI-DI: 10888277407602 (each) 20888277407609 (case), Lot Number: EP240528; 401904R UDI-DI: 10888277407510 (each) 20888277407609 (case), Lot Number: EP240805; 401905R UDI-DI: 10888277407510 (each) 20888277407616 (case), Lot Number: EP240528; 401933R UDI-DI: 10888277407688 (each) 20888277407685 (case), Lot Number: EP240528; 401991R UDI-DI: 10888277407756 (each) 20888277407753 (case), Lot Number: EP240528;

UPC codes

10888277407510, 20888277407517, 10888277407602, 20888277407609, 20888277407616, 10888277407688, 20888277407685, 10888277407756, 20888277407753

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.