Z-1460-2025 Class II Ongoing
FDA device recall Z-1460-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on February 6, 2025 and is designated Class II. Reason for recall: Devices may have higher than expected amounts of bacterial endotoxin. The recall status is ongoing. Affected quantity: 74 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 2, 2025
- Initiation Date
- February 6, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 74 units
Product Description
Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
Reason for Recall
Devices may have higher than expected amounts of bacterial endotoxin.
Distribution Pattern
US Nationwide distribution in the states of AR, AZ, CA, CO, IA, IL, KS, OR, TN, TX, WA, and WI.
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;