Medical device recalls Moderate risk

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

Recall date
March 25, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1513-2015
FDA classification
Class II
Brand / firm
CSA Medical
Sold / distributed
Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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