FDA-Device2015-04-29Class II

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

CSA Medical
Hazard

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

Sold states
Nationwide
Affected count
82 units
Manufactured in
91 Hartwell Ave, Lexington, MA, United States
Products
CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1513-2015

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