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U.S. Department of Health and Human Services

Class 3 Device Recall SurgiFrost 7 cm CryoSurgical device plus FrostByte Clamp

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 Class 3 Device Recall SurgiFrost 7 cm CryoSurgical device plus FrostByte Clampsee related information
Date Initiated by FirmMay 05, 2006
Date PostedOctober 28, 2006
Recall Status1 Terminated 3 on November 02, 2006
Recall NumberZ-0079-2007
Recall Event ID 35745
510(K)NumberK053436 
Product Classification Cryo surgical clamp - Product Code GEH
ProductCryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec, Canada. The product consists of a cryosurgical probe (SurgiFrost 7 cm) plus Clamp (FrostByte) packaged for use with Cryosurgical console.
Code Information Lot: 50515, 50602, 50609
FEI Number 3008592544
Recalling Firm/
Manufacturer		 ATS Medical, Inc.
3905 Annapolis Ln N Ste 105
Minneapolis MN 55447-5473
Manufacturer Reason
for Recall		Incorrect Expiration Date: Three lots of the FrostByte (TM) clamp packaged with SurgiFrost 7 cm cryosurgical probes have incorrect expiration dates. These lots are labeled with a two (2) year expiratation date while the correct date is one (1) year.
FDA Determined
Cause 2		Other
ActionConsignee''s were notified by ATS Medical Representatives via visits. Product was either relabeled with correct expiration date or retrieved by ATS Medical representatives.
Quantity in Commerce219 units
DistributionNationwide-ATS Medical distirubted devices to hospitals located in the following states IN, KS, MO, TX. There may be other US distributors of this product.
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 = GEH
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