Cooper Surgical, Inc. Wallach LL100 Cryosurgical Freezer CO2 Unpinned Yoke System CO2 Model: 900000. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Wallach LL100 Cryosurgical Freezer CO2 Unpinned Yoke System CO2 Model: 900000.
Brand
Cooper Surgical, Inc.
Lot Codes / Batch Numbers
Serial Number Prefixes of Affected Product: A, AN, DN, EN, FA, JN, LN, 03, 04, 07, 08, 09, 11, 12
Products Sold
Serial Number Prefixes of Affected Product: A, AN,DN, EN, FA, JN, LN, 03, 04, 07, 08, 09,11,12
Cooper Surgical, Inc. is recalling Wallach LL100 Cryosurgical Freezer CO2 Unpinned Yoke System CO2 Model: 900000. due to 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 co. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026