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Terminated

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.

FDA Recall Z-0116-2016 · Posted 2015-10-09

Recalling FirmConcentric Medical Inc
Recall StatusTerminated
Product CodeDQY
Date Initiated2015-08-19
Date Terminated2015-10-09
Product Quantity1

Reason for Recall

One Distal Access Catheter intended for distribution in Korea, was found at a US location.

Firm 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.

Root Cause

Employee error

Distribution Pattern

US Distribution to one location in KY.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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