🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: November 10, 2014 CSA Medical Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
CSA Medical
Reason for Recall:
An increase in complaint trending for a loss of audible sound associated with the timer has been observed.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0941-2015

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