Recall Z-2412-2023 ยท JXG Shunt, Central Nervous System And Components
Medtronic Neurosurgery
Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
| Date | Aug 17, 2023 (initiated Jun 28, 2023) |
| Status | Open, Classified |
| Reason | Product labeling contains incorrect expiration date |
| Root cause | Labeling Change Control |
| Action | On June 28, 2023, Medtronic Neurosurgery issued a "Urgent: Medical Device Recall" Notification to affected consignees via FedEx and email. Medtronic asked consignees to take the following actions: 1. Immediately identify and quarantine unused affected products within your inventory. 2. Return the affected product per the return instructions listed in the Customer Confirmation Form. 3. Complete and return the Customer Confirmation Form, even if you do not have any affected product. 4. Share this recall notification with all who need to be aware within your organization or to any organizati |
| Quantity | 44 units |
| Distribution | US Nationwide distribution in the states of NJ, FL, CA, IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984053 | BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM Medtronic PS Medical, Feb 4, 1999 |