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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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Product Detail

Product Description 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.
Recall Number Z-0560-2014
Classification Class III
Code Info Lot Number: 11211566.1, Exp. Date: 09/01/2017.
Product Distributed Qty 3
Reason For Recall 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.

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.