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U.S. Department of Health and Human Services

Class 2 Device Recall Wallach Cryotip

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  Class 2 Device Recall Wallach Cryotip see related information
Date Initiated by Firm June 06, 2007
Date Posted July 11, 2007
Recall Status1 Terminated 3 on July 15, 2015
Recall Number Z-1045-2007
Recall Event ID 38072
510(K)Number K803311  
Product Classification Cryosurgical instrument - Product Code GEH
Product Wallach Cryotip T-00337 Anorectal Tip used with the Cryosurgical LL100 or LL50X Cryosurgical Systems
Reference: 900218
Code Information All lots
Recalling Firm/
Manufacturer		 Wallach Surgical Devices, Inc.
235 Edison Road
Orange CT 06477-3603
For Additional Information Contact Gary LeMere
203-799-2000
Manufacturer Reason
for Recall		 The tip may separate from the probe.
FDA Determined
Cause 2		 Device Design
Action Wallach Surgical notified accounts by fax on 6/6/07. A follw-up telephone call will be made to the 70 domestic consignees. Foreign consignees notiifed by fax or email with follow-up telephone calls. Accounts are requested to return product and replace with an alternate product.
Quantity in Commerce 315 units
Distribution Worldwide, including USA, Canada, Australia, England, Greece, Jordan, Turkey, Hungary, Netherlands, Saudi Arabia, Spain, and Lithuania
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 = WALLACH SURGICAL DEVICES, INC.
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