Recall Z-1513-2015— CSA Medical
Class II · Terminated
Class II FDA medical device recall by CSA Medical, initiated 2015-03-25, terminated 2015-08-21. It names one FDA 510(k) clearance: K143625. Product: CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01. Reason: TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax.
- Recalling firm
- CSA Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-25
- Terminated
- 2015-08-21
- Firm location
- Lexington, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.