Recall Z-0560-2014— Edwards Lifesciences, LLC
Class III · Terminated
Class III FDA medical device recall by Edwards Lifesciences, LLC, initiated 2013-11-20, terminated 2014-02-10. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Edwards Lifesciences, LLC
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-11-20
- Terminated
- 2014-02-10
- Firm location
- Draper, UT, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.