CSA Medical truFreeze System Recalled for Timer Sound Loss
CSA Medical is recalling 46 truFreeze cryogenic surgical devices because the timer may lose its audible sound, potentially affecting surgical procedures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect (loss of timer sound) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
CSA Medical is recalling 46 units of the truFreeze System (Model CC3-01), a cryogenic surgical device used for the destruction of tissue in dermatology, gynecology, and general surgery. The recall involves specific units equipped with the newest version of a panel PC referred to as POC-127, identified by specific serial numbers listed in the agency's records.
The recall was initiated due to an increase in complaints regarding a loss of audible sound associated with the device's timer. This defect could potentially impact the timing of surgical procedures that rely on the audible alert.
The affected devices were distributed in the United States to the states of Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, North Carolina, New Jersey, New York, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, and West Virginia. Healthcare providers and facilities should check their inventory for the specific serial numbers listed in the recall notice and contact CSA Medical for instructions on how to proceed.
The recalled product
- Product
- CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of t
- Manufacturer
- CSA Medical
- Affected units
- 46
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Console SN/Lot NO: 01-00109
- 01-00112
- 01-00113
- 01-00115
- 01-00120
- 01-00121
- 01-00122
- 01-00123
- 01-00132
- 01-00133
- 01-00135
- 01-00137
- 01-00142
- 01-00148
- 01-00156
- 01-00159
- 01-00160
- 01-00161
- 01-00162
- 01-00163
Distribution
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