Z-1045-2007

Wallach Cryotip T-00337 Anorectal Tip used with the Cryosurgical LL100 or LL50X Cryosurgical Systems...

Name: Z-1045-2007 Wallach Cryotip T-00337 Anorectal Tip used with the Cryosurgical LL100 or LL50X Cryosurgical Systems...
Creator: Wallach Surgical Devices, Inc.
Published: 2007-06-06
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2007-06-06 / Terminated / root cause: design

FDA source

Wallach Surgical Devices, Inc. began a recall of Wallach Cryotip T-00337 Anorectal Tip used with the Cryosurgical LL100 or LL50X Cryosurgical Systems Reference: 900218 on 2007-06-06. The reason FDA records is "The tip may separate from the probe". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1045-2007
Status: Terminated
Initiated: 2007-06-06
Posted: 2007-07-11
Terminated: 2015-07-15
Recalling firm: CooperSurgical, Inc.
Product: Wallach Cryotip T-00337 Anorectal Tip used with the Cryosurgical LL100 or LL50X Cryosurgical Systems Reference: 900218
Product code: GEH Unit, Cryosurgical, Accessories
Reason for recall: The tip may separate from the probe.
Root cause tag: design
FDA root 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
Product codes and lots: All lots

Product code GEH

K803311Class IILl100 Cryosurgical SystemWallach Surgical Devices, Inc. / cleared 1981-02-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)