Class II — CSA Medical
| Recalling firm | CSA MEDICAL, INC. |
|---|---|
| Registered facility | CSA Medical (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | An increase in complaint trending for a loss of audible sound associated with the timer has been observed. |
| Product | CSA Medical truFreeze System; Model: CC3-01, 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. |
| Quantity | 46 |
| Distribution | US Distribution to states of: AR, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, NC, NJ, NY, OK, PA, RI, SC, TN, TX, UT, VA, and WV. |
| Initiated | 2014-11-10 |
| Classified | 2015-01-07 |
| Terminated | 2015-03-25 |
| Recall number | Z-0941-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CSA Medical (Z-0941-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69806/
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