The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the d
FDA device recall Z-1740-2024 · posted 2024-05-01 · Open, Classified
Recall details
- Recalling firm
- Stryker Neurovascular
- Reason for recall
- 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.
- Action taken
- 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 the firm of any adverse events concerning the use of the subject devices. (US Customer Service: 1-855-91-NEURO (1-855-916-3876), Email: NVCustomerCare@stryker.com) 5) Complete and return the customer response form to nvfieldactions@stryker.com
- Root cause
- Release of Material/Component prior to receiving test results
- Status
- Open, Classified
- Product code
- DQY
- Quantity affected
- 43
- Distribution
- US Nationwide distribution in the states of TX, FL, NJ, CO, LA, NC, AL, PA, MI, MS, SC, IL.
- Date initiated
- 2024-04-03
- Date posted
- 2024-05-01
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFIED HD GUIDE CATHETER (K133177) | Concentric Medical, Inc. | 2014-02-25 |