FDAClass IIIJanuary 1, 2014

Edwards Lifesciences Ergonic Double Acting DeBakey recall: Labeling Error

Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical Instruments are…

Why was Edwards Lifesciences Ergonic Double Acting DeBakey 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical Instruments are…
Recalling firm
Edwards Lifesciences, LLC
Quantity
3
Distribution
Distributed to 3 customers in FL only.
Recall date
January 1, 2014
Classification
Class III
Status
Terminated
Agency
FDA (device)
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