Recall Z-1460-2025 ยท NLH Catheter, Recording, Electrode, Reprocessed
MEDLINE INDUSTRIES, LP - Northfield
Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
| Date | Mar 26, 2025 (initiated Feb 6, 2025) |
| Status | Open, Classified |
| Reason | Devices may have higher than expected amounts of bacterial endotoxin. |
| Root cause | Under Investigation by firm |
| Action | An IMMEDIATE ACTION REQUIRED notification letter dated 2/6/25 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item numbers and the affected lot numbers listed on the attachment. Quarantine all affected product. 2. Please return the completed enclosed response form listing the quantity of affected product on hand. Even if you do not have any affected product, please complete and return the form, as indicated on the response form. When we receive your completed response form you will be sent FedEx return labels to return the product back to Medline ReNew |
| Quantity | 74 units |
| Distribution | US Nationwide distribution in the states of AR, AZ, CA, CO, IA, IL, KS, OR, TN, TX, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221067 | Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter Surgical Instrument Service and Savings, Inc., May 31, 2023 |