Device product
Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
Z-1460-2025
Product summary
- Event
- Event 96368
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 74 units
- Official record key
device-enforcement:Z-1460-2025
Official wording
Reason: Devices may have higher than expected amounts of bacterial endotoxin.
Code information: 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;
Distribution pattern: US Nationwide distribution in the states of AR, AZ, CA, CO, IA, IL, KS, OR, TN, TX, WA, and WI.
Derived failure modes
-
Unknown
Devices may have higher than expected amounts of bacterial endotoxin.