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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 Cryotipsee related information
Date Initiated by FirmJune 06, 2007
Date PostedJuly 11, 2007
Recall Status1 Terminated 3 on July 15, 2015
Recall NumberZ-1046-2007
Recall Event ID 38072
510(K)NumberK803311 
Product Classification Cryosurgical instrument - Product Code GEH
ProductWallach Cryotip T-00337 Anorectal Tip, Teflon Coated, used with the Cryosurgical LL100 or LL50X Reference: 900220
Code Information All lots
Recalling Firm/
Manufacturer
Wallach Surgical Devices, Inc.
235 Edison Road
Orange CT 06477-3603
For Additional Information ContactGary LeMere
203-799-2000
Manufacturer Reason
for Recall
The tip may separate from the probe.
FDA Determined
Cause 2
Device Design
ActionWallach 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 Commerce14 units
DistributionWorldwide, including USA, Canada, Australia, England, Greece, Jordan, Turkey, Hungary, Netherlands, Saudi Arabia, Spain, and Lithuania
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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