Wallach LL100 Cryosurgical Freezer CO2 System Model: 900043.

FDA device recall Z-0098-2010 · posted 2009-10-29 · Terminated

Recall details

Recalling firm

Cooper Surgical, Inc.

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

GEH

Distribution

Worldwide Distribution -- United States, Canada, Australia, Belgium, England, France, Germany, Greece, Hungary, Iceland, Italy, Ireland, Latvia, Lithuania, Netherlands, Portugal, Spain, Solvenia, Swed

Date initiated

2009-09-29

Date posted

2009-10-29

Date terminated

2012-04-17

Location

Trumbull, CT