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Terminated

Wallach Cryotip T-00337 Anorectal Tip used with the Cryosurgical LL100 or LL50X Cryosurgical Systems Reference: 900218

FDA Recall Z-1045-2007 · Posted 2007-07-11

Recalling FirmWallach Surgical Devices, Inc.
Recall StatusTerminated
Product CodeGEH
Date Initiated2007-06-06
Date Terminated2015-07-15
Product Quantity315 units

Reason for Recall

The tip may separate from the probe.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Worldwide, including USA, Canada, Australia, England, Greece, Jordan, Turkey, Hungary, Netherlands, Saudi Arabia, Spain, and Lithuania

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K803311LL100 CRYOSURGICAL SYSTEMWallach Surgical Devices, Inc. · 1981-02-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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