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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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Event Detail

Event ID 66934
Product Type Devices
Status Ongoing
Recalling Firm Edwards Lifesciences, LLC
City Draper
State UT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-20
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Distributed to 3 customers in FL only.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical Instruments are designed to perform specialized functions in specific cardiac surgical or endoscopic procedures. Lot Number: 11211566.1, Exp. Date: 09/01/2017. Class III Edwards Lifesciences is recalling one lot of Ergonic instrument due to mislabeling. Ergonic scissors standard curved labeled as a Double Acting DeBakey forcep. Edwards control confirmed that the laser etching on the device was incorrect. 3 Z-0560-2014
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