Z-1513-2015 Class II Terminated
FDA device recall Z-1513-2015 was initiated by CSA Medical on March 25, 2015 and is designated Class II. Reason for recall: TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax The recall status is terminated (terminated August 21, 2015). Affected quantity: 82 units.
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