Reported Jan 14, 2015 · Terminated
CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the…
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 System
- ModelCC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions
- Lot codes and dates
- Console SN/Lot NO
01-0010901-0011201-0011301-0011501-0012001-0012101-0012201-0012301-0013201-0013301-0013501-0013701-0014201-0014801-0015601-0015901-0016001-0016101-0016201-0016301-0016501-0016601-0016801-0016901-0017001-0017101-0017201-0017301-0017401-0017501-0017601-0017701-0017801-0017901-0018001-0018101-0018201-0018301-0018501-0018601-0018701-0018801-0018901-0019001-0019101-00192
- Console SN/Lot NO
- Amount recalled
- 46
Where it was sold
Why it was recalled
An increase in complaint trending for a loss of audible sound associated with the timer has been observed.
This product could cause temporary or reversible health problems — stop using it.
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