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CSA Medical

2 recalls •

🏥 Medical Devices

• Categories: Surgical Instruments

CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01

Class I - Dangerous

TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax

Mar 25, 2015 Surgical Instruments Nationwide View Details →

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.

Class I - Dangerous

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

Nov 10, 2014 Surgical Instruments Nationwide View Details →