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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 Clamp see related information
Date Initiated by Firm May 05, 2006
Date Posted October 28, 2006
Recall Status1 Terminated 3 on November 02, 2006
Recall Number Z-0079-2007
Recall Event ID 35745
510(K)Number K053436  
Product Classification Cryo surgical clamp - Product Code GEH
Product CryoCath 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
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
Action Consignee''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 Commerce 219 units
Distribution Nationwide-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 Cycle TPLC 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) Database 510(K)s with Product Code = GEH and Original Applicant = CRYOCATH TECHNOLOGIES, INC.
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