CSA Medical recalls CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newes…

Recall date

November 10, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0941-2015

FDA classification

Class II

Brand / firm

CSA Medical

Sold / distributed

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.

Why it was recalled

An increase in complaint trending for a loss of audible sound associated with the timer has been observed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.