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U.S. Department of Health and Human Services

Enforcement Report - Week of February 27, 2013

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Event Detail

Event ID 63933
Product Type Devices
Status Ongoing
Recalling Firm Healthtronics, Inc.
City Austin
State TX
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-20
Initial Firm Notification of
Consignee or Public
Distribution Pattern CA, CO, FL, GA, NC, NJ, OH, TX, and WI. No international distribution.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L, Endocare, Inc., a wholly owned subsidiary of HealthTronics, Inc., 9825 Spectrum Dr. Building 3, Austin, TX 78717 The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System. The CryoCare Surgical System is intended for use in surgical procedures in the arrears of general surgery, dermatology, neurology, thoracic surgery, pulmonary surgery, Lot 10180, Expiration date on box is 2105-07. Model Number R3.8L Class II The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date. 50 units Z-0825-2013