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Recall Observatory FDA recall evidence

Device product

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.

Z-0560-2014

November 20, 2013

Class III

Product summary

Firm
Edwards Lifesciences, LLC
Event
Event 66934
Status
Terminated
Classification
Class III
Quantity
3
Official record key
device-enforcement:Z-0560-2014

Official wording

Reason: 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.

Code information: Lot Number: 11211566.1, Exp. Date: 09/01/2017.

Distribution pattern: Distributed to 3 customers in FL only.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeling