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.
- Company
- Concentric Medical Inc
- Recall Initiated
- August 19, 2015
- Posted
- October 9, 2015
- Terminated
- October 9, 2015
- Recall Number
- Z-0116-2016
- Quantity
- 1
- Firm Location
- Mountain View, CA
Reason for Recall
One Distal Access Catheter intended for distribution in Korea, was found at a US location.
Distribution
US Distribution to one location in KY.
Lot / Code Info
Lot no. 37603 Expiration date: September 2016
Root Cause
Employee error
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.
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