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.
Reported: January 1, 2014 Initiated: November 20, 2013 #Z-0560-2014
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.
Details
- Recalling Firm
- Edwards Lifesciences, LLC
- Units Affected
- 3
- Distribution
- Distributed to 3 customers in FL only.
- Location
- Draper, UT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Edwards Lifesciences, LLC. Units affected: 3.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2014. Severity: Low. Recall number: Z-0560-2014.
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