Z-0093-2010

Wallach LL50x Cryosurgical Freezer CO2 System Model: 900007

Name: Z-0093-2010 Wallach LL50x Cryosurgical Freezer CO2 System Model: 900007
Creator: Cooper Surgical, Inc.
Published: 2009-09-29
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2009-09-29 / Terminated / root cause: design

FDA source

Cooper Surgical, Inc. began a recall of Wallach LL50x Cryosurgical Freezer CO2 System Model: 900007 on 2009-09-29. The reason FDA records is "CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the...". 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-0093-2010
Status: Terminated
Initiated: 2009-09-29
Posted: 2009-10-29
Terminated: 2012-04-17
Recalling firm: CooperSurgical, Inc.
Product: Wallach LL50x Cryosurgical Freezer CO2 System Model: 900007.
Product code: GEH Unit, Cryosurgical, Accessories
Reason for recall: CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve.
Root cause tag: design
FDA root cause: Device Design
Action: Cooper Surgical notified customers by letter titled "Notice of Recall - Urgent" dated September 29, 2009 advising them of the problem and requesting return of the device. International accounts were notified by letter Beginning October 1, 2009. For further information, contact Cooper Surgical by fax at 1-203-799-2002 or phone at 1-203-799-2000.
Distribution: Worldwide Distribution -- United States, Canada, Australia, Belgium, England, France, Germany, Greece, Hungary, Iceland, Italy, Ireland, Latvia, Lithuania, Netherlands, Portugal, Spain, Solvenia, Sweden, Hong Kong, Republic of China, Taiwan, Angola, Cameroon, Congo, Croatia, Egypt, Ghana, Guam, Guineae Bissau, Indonesia, Kenya, Kuwait, Lebanon, Madagascar, Mali, Mauritania, Mozambique, New Zealand, Niger, Pakistan,Qatar, Russia, Sao Tome, Saudi Arabia, Senegal, Serbia, Singapore, South Africa, St Vincents & Grenadines, Oman, Thailand, Turkey, UAE and Zimbabwe.
Product codes and lots: Serial Number Prefixes of Affected Product: A, X, 10

Product code GEH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)