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U.S. Department of Health and Human Services

Class 2 Device Recall Cryosurgical Freezer

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  Class 2 Device Recall Cryosurgical Freezer see related information
Date Initiated by Firm September 29, 2009
Date Posted October 29, 2009
Recall Status1 Terminated 3 on April 17, 2012
Recall Number Z-0098-2010
Recall Event ID 53436
510(K)Number K803311   
Product Classification Unit, cryosurgical, accessories - Product Code GEH
Product Wallach LL100 Cryosurgical Freezer CO2 System
Model: 900043.
Code Information Serial Number Prefixes of Affected Product: AK
Recalling Firm/
Cooper Surgical, Inc.
95 Corporate Dr
Trumbull CT 06611
For Additional Information Contact
203-601-5200 Ext. 8725
Manufacturer 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.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.