Enforcement Report - Week of February 27, 2013
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Product Detail
| Product Description | 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, |
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| Recall Number | Z-0825-2013 |
| Classification | Class II |
| Code Info | Lot 10180, Expiration date on box is 2105-07. Model Number R3.8L |
| Product Distributed Qty | 50 units |
| Reason For Recall | The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date. |
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 | Letter |
| Distribution Pattern | CA, CO, FL, GA, NC, NJ, OH, TX, and WI. No international distribution. |
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