FDA Medical Device Recalls (openFDA)
Cooper Surgical, Inc.: Wallach LL100 Cryosurgical Freezer CO2 Unpinned Yoke System CO2 Model: 900000.
- Recall number
- Z-0091-2010
- Recalling firm
- Cooper Surgical, Inc.
- Product
- Wallach LL100 Cryosurgical Freezer CO2 Unpinned Yoke System CO2 Model: 900000.
- Status
- Terminated
- Initiated
- 2009-09-29
- Posted
- 2009-10-29
- Terminated
- 2012-04-17
- Reason
- 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
- 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.
- Quantity
- 3,044 units
- 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.
- Lot, serial or model codes
- Serial Number Prefixes of Affected Product: A, AN,DN, EN, FA, JN, LN, 03, 04, 07, 08, 09,11,12
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GEH
- Firm FEI
- 1216677
- Firm city
- Trumbull
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28