Recall Z-2460-2025 ยท NLH Catheter, Recording, Electrode, Reprocessed
MEDLINE INDUSTRIES, LP - Northfield
Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH, 401260RH, 401261RH, 401271RH, 401305RH, 401306RH, 401309RH, 401310RH, 401311RH, 401312RH, 401317RH, 401353RH, 401357RH, 401381RH, 401392RH, 401399RH, 401400RH, 401425RH, 401430RH,
| Date | Aug 28, 2025 (initiated Jul 14, 2025) |
| Status | Open, Classified |
| Reason | Specific lots of reprocessed electrophysiology catheters may contain small residual particulates. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Recall notification letter dated 7/14/25 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed on the enclosed response form. Quarantine all affected product immediately. 2. Please complete and return the enclosed response form via email to: recalls@medline.com or fax: 866-767-1290, listing the quantity of affected product you have in inventory. Even if you do not have any affected product in inventory, please complete and return the response form. 3. Upon receipt of your submitted |
| Quantity | 398 units |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K241156 | Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (40 Surgical Instrument Service and Savings, Inc., Sep 14, 2024 |