FDAClass IIJanuary 14, 2015

CSA Medical truFreeze System recall

CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC…

Why was CSA Medical truFreeze System recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models 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

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…
Recalling firm
CSA Medical
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.
Recall date
January 14, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls