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CSA Medical recalls CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the new
Recalled January 14, 2015 · FDA recall Z-0941-2015 · CSA Medical
Hazard
An increase in complaint trending for a loss of audible sound associated with the timer has been observed. · FDA Class II
Units
46
Sold at
US Distribution to states of: AR, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, NC, NJ, NY, OK, PA, RI, SC, TN, TX, UT, VA, and WV.
Description
An increase in complaint trending for a loss of audible sound associated with the timer has been observed.
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 tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.
Manufacturer(s)
CSA Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →