Home / Recalls / CSA Medical / Z-1513-2015

Z-1513-2015 Class II Terminated

Recalled by CSA Medical — Lexington, MA

Recall Details

Product Type: Devices
Report Date: April 29, 2015
Initiation Date: March 25, 2015
Termination Date: August 21, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 82 units

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

Serial Numbers: 01-00106 through 01-00201