| Class 2 Device Recall Cryosurgical Freezer | |
Date Initiated by Firm | September 29, 2009 |
Date Posted | October 29, 2009 |
Recall Status1 |
Terminated 3 on April 17, 2012 |
Recall Number | Z-0092-2010 |
Recall Event ID |
53436 |
Product Classification |
Unit, cryosurgical, accessories - Product Code GEH
|
Product | Wallach LL100 Cryosurgical Freezer CO2 System
Model: 9000002X. |
Code Information |
Serial Number Prefixes of Affected Product: A, FA, 02,03, 04, 05,06, 07, 08, 09, 10,11 |
Recalling Firm/ Manufacturer |
Cooper Surgical, Inc. 95 Corporate Dr Trumbull CT 06611
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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 |
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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.
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