Recall Z-1740-2024 ยท DQY Catheter, Percutaneous
Stryker Neurovascular
The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration are shown on the product label. A rotating hemostasis valve with side-arm adapter is provided with each catheter. The rota
| Date | May 1, 2024 (initiated Apr 3, 2024) |
| Status | Open, Classified |
| Reason | Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results. |
| Root cause | Release of Material/Component prior to receiving test results |
| Action | On 4/3/24, recall notices were mailed to Supply Chain Management/ Recall Coordinator/ Inventory Managers informing them: 1) Segregate the affected units in a secure location for return to the firm. Circulate this Recall-Removal notice internally to all interested/affected parties. 2) Maintain awareness of this communication internally until all required actions have been completed within your facility. 3) Inform the firm if any of the subject devices have been distributed to other organizations. If yes, provide contact details so the firm can inform the recipients appropriately. 4) Inform th |
| Quantity | 43 |
| Distribution | US Nationwide distribution in the states of TX, FL, NJ, CO, LA, NC, AL, PA, MI, MS, SC, IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133177 | MODIFIED HD GUIDE CATHETER Concentric Medical, Inc., Feb 25, 2014 |