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U.S. Department of Health and Human Services

Class 2 Device Recall CryoCath

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 Class 2 Device Recall CryoCathsee related information
Date Initiated by FirmOctober 25, 2002
Date PostedApril 16, 2003
Recall Status1 Terminated 3 on April 15, 2003
Recall NumberZ-0728-03
Recall Event ID 25856
Product Classification Unit, Cryosurgical, Accessories - Product Code GEH
ProductSurgiFrost Cryosurgical Probes
Code Information Lots 02-0464; 02-0474; 02-0578; 02-0711; 02-0852; 02-0911; 02-0981; 02-0982
Recalling Firm/
Manufacturer		 Endocare Inc
201 Technology Drive
Irvine CA 92618
Manufacturer Reason
for Recall		Device design failure, connectivity.
FDA Determined
Cause 2		Other
ActionThis recall has been completed. Recall notice was sent by fax on October 25, 2002.
Quantity in Commerce933
DistributionProduct was sent only to one Canadian distribution company whoin turn sold it internationally and back to the USA.
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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