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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmSeptember 26, 2005
Date PostedJanuary 10, 2006
Recall Status1 Terminated 3 on January 10, 2006
Recall NumberZ-0368-06
Recall Event ID 33700
Product Classification Device, Vascular, For Promoting Embolization - Product Code KRD
ProductCook brand Embolization Coils, stainless steel, sterile, 20 MM diameter, .038'' (0.97 mm) diameter embolus, 20 MM diameter, 20 MM long For use with .038'' end hole; Reorder # MWCE-38-20-20.
Code Information Lots F512190X, F612598, F712671, F782158, F1015070, F1246233, F1296872, F1306174, F1324630, F1333380, F1345472, F1395273 and F1479165.
FEI Number 1820334
Recalling Firm/
Manufacturer		 Cook, Inc.
750 Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact
800-346-2686
Manufacturer Reason
for Recall		The coil is 20 centimeters in length, but the label states the length is 20 millimeters.
FDA Determined
Cause 2		Other
ActionConsignees were notified via telephone and recall letter dated September 26, 2005.
Quantity in Commerce242
DistributionDelaware, New York and Pennsylvania.
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.
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