Wallach Cryotip T-00337 Anorectal Tip, Teflon Coated, used with the Cryosurgical LL100 or LL50X Reference: 900220
FDA Recall Z-1046-2007 · Posted 2007-07-11
Recalling FirmWallach Surgical Devices, Inc.
Recall StatusTerminated
Product CodeGEH
Date Initiated2007-06-06
Date Terminated2015-07-15
Product Quantity14 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.