Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in fac
FDA device recall Z-0525-2015 · posted 2014-12-12 · Terminated
Recall details
- Recalling firm
- Concentric Medical Inc
- Reason for recall
- Distal Access Catheters were shipped to US customers with the Directions for Use that included instructions for aspiration. This version of the DFU is only approved outside of the US.
- Action taken
- The firm, Concentric Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated September 26, 2013 consignees/customers at all affected sites by registered mail. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to immediately locate the subject devices and quarantine them; distribute notice to all affected departments in your facility; inform Concentric Medical (Stryker Neuovascular) if any of the subject devices have been distributed to other organizations; complete, sign and return the attached Customer Response Form via Fax to: 1-866-876-4355 or email a copy to: NeuroComplaints@stryker.com, complete form even if you do not have any subject devices to return, and keep a copy of the completed, signed Customer Response Form for your records. Should you have any queries concerning this matter, please do not hesitate to contact the QA Manager at 650-810-1716.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 87 units
- Distribution
- US Distribution to states of: TX, TN, PA, MI, VA, CA, NC, MS, FL, IL, MA, AZ, OK, NY, KY, WA, and AL.
- Date initiated
- 2013-09-26
- Date posted
- 2014-12-12
- Date terminated
- 2014-12-08
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFIED HD GUIDE CATHETER (K110483) | Concentric Medical, Inc. | 2011-04-04 |