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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