CLASS II Device recall · Reported 14 Jan 2015 · FDA Enforcement Report

truFreeze System recalled by CSA Medical

CSA Medical is recalling CSA Medical truFreeze System, distributed in 25 states. The recall was initiated on 10 Nov 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesConsole SN/Lot NO: 01-00109, 01-00112, 01-00113, 01-00115, 01-00120, 01-00121, 01-00122, 01-00123, 01-00132, 01-00133, 01-00135, 01-00137, 01-00142, 01-00148, 01-00156, 01-00159, 01-00160, 01-00161, 01-00162, 01-00163, 01-00165, 01-00166, 01-00168, 01-00169, 01-00170, 01-00171, 01-00172, 01-00173, 01-00174, 01-00175, 01-00176, 01-00177, 01-00178, 01-00179, 01-00180, 01-00181, 01-00182, 01-00183, 01-00185, 01-00186, 01-00187, 01-00188, 01-00189, 01-00190, 01-00191, 01-00192

Quantity recalled46

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0941-2015
FDA event ID: 69806
Recalling firm: CSA Medical, Lexington, MA
Classification: Class II
Status: Terminated
Recall initiated: 10 Nov 2014
FDA classified: 7 Jan 2015
Reported: 14 Jan 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

10 Nov 2014	Recall initiated by company
7 Jan 2015	Classified by FDA	+58 days
14 Jan 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

An increase in complaint trending for a loss of audible sound associated with the timer has been observed.

Product as listed by the FDA

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.

Where it was distributed

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.

Arkansas California Colorado Connecticut District of Columbia Florida Georgia Illinois Indiana Louisiana Massachusetts Maryland Michigan North Carolina New Jersey New York Oklahoma Pennsylvania Rhode Island South Carolina

Questions about this recall

Is truFreeze System recalled?

Yes. CSA Medical recalled truFreeze System on 10 Nov 2014. The recall is Class II and its status is Terminated. Recall number Z-0941-2015.

Why was it recalled?

An increase in complaint trending for a loss of audible sound associated with the timer has been observed.

Which lots are affected?

Console SN/Lot NO: 01-00109, 01-00112, 01-00113, 01-00115, 01-00120, 01-00121, 01-00122, 01-00123, 01-00132, 01-00133, 01-00135, 01-00137, 01-00142, 01-00148, 01-00156, 01-00159, 01-00160, 01-00161, 01-00162, 01-00163, 01-00165, 01-00166, 01-00168, 01-00169, 01-00170, 01-00171, 01-00172, 01-00173, 01-00174, 01-00175, 01-00176, 01-00177, 01-00178, 01-00179, 01-00180, 01-00181, 01-00182, 01-00183, 01-00185, 01-00186, 01-00187, 01-00188, 01-00189, 01-00190, 01-00191, 01-00192

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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