Device recall

Z-0560-2014: Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight…

FDA device recall · Class III · Edwards Lifesciences, LLC

Key facts

Recall number (Z-number) Z-0560-2014
Recall event 66934
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.
Product code HTD
Recalling firm Edwards Lifesciences, LLC
Recall class Class III
Status Terminated
Termination date Feb 10, 2014
FEI number 1713910

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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