Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Cathet
FDA device recall Z-0116-2016 · posted 2015-10-09 · Terminated
Recall details
- Recalling firm
- Concentric Medical Inc
- Reason for recall
- One Distal Access Catheter intended for distribution in Korea, was found at a US location.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 1
- Distribution
- US Distribution to one location in KY.
- Date initiated
- 2015-08-19
- Date posted
- 2015-10-09
- Date terminated
- 2015-10-09
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFIED HD GUIDE CATHETER (K133177) | Concentric Medical, Inc. | 2014-02-25 |