Recall Z-0116-2016 ยท DQY Catheter, Percutaneous
Concentric Medical Inc
Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.
| Date | Oct 9, 2015 (initiated Aug 19, 2015) |
| Status | Terminated |
| Reason | One Distal Access Catheter intended for distribution in Korea, was found at a US location. |
| Root cause | Employee error |
| Action | Issue was discovered by a sales representative during a visit for a case in Kentucky, where multiple Distal Access Catheters (DAC's) were being used. It was noticed that the reference number on one DAC carton did not match, even through the product labeling appeared to be the same. The mismatched unit was removed and returned to Concentric (Stryker). A formal recall letter was not issued as the product was returned after discovery. For further questions please call (510) 413-2263. |
| Quantity | 1 |
| Distribution | US Distribution to one location in KY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133177 | MODIFIED HD GUIDE CATHETER Concentric Medical, Inc., Feb 25, 2014 |