Reported Apr 29, 2015 · Terminated
CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01
CSA Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CSA Medical · 91 Hartwell Ave · Lexington, MA · 02421-3137
Is this the product you have?
- CSA Medical truFreeze Console- Cryosurgical
- Unit Cryogenic Surgical Device ModelCC3-01
- Lot codes and dates
- Serial Numbers01-00106 through 01-00201
- Amount recalled
- 82 units
Where it was sold
- 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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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