Class 2 Device Recall Wallach Cryotip

• Date Initiated by Firm: June 06, 2007
• Date Posted: July 11, 2007
• Recall Status: Terminated 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: 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