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
Product summary
- 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
mislabeling