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U.S. Department of Health and Human Services

Class 2 Device Recall Distal Access Catheter (DAC)

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 Class 2 Device Recall Distal Access Catheter (DAC)see related information
Date Initiated by FirmAugust 19, 2015
Date PostedOctober 09, 2015
Recall Status1 Terminated 3 on October 09, 2015
Recall NumberZ-0116-2016
Recall Event ID 72247
510(K)NumberK133177 
Product Classification Catheter, percutaneous - Product Code DQY
ProductDistal 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.
Code Information Lot no. 37603 Expiration date: September 2016
Recalling Firm/
Manufacturer		 Concentric Medical Inc
301 E Evelyn Ave
Mountain View CA 94041-1530
For Additional Information ContactGary Rebman
510-413-2263
Manufacturer Reason
for Recall		One Distal Access Catheter intended for distribution in Korea, was found at a US location.
FDA Determined
Cause 2		Employee error
ActionIssue 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 in Commerce1
DistributionUS Distribution to one location in KY.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DQY
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