Reported Aug 12, 2020 · Terminated

Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments. The bipolar for-ceps…

Sutter Medizintechnik GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Sutter Medizintechnik GmbH · Tullastr. 87 · Freiburg Im Breisgau · N/A

Is this the product you have?

  • Sutter Swyng non-stick
  • bipolar forceps - Product Usagesingle-use re electrosurgical instruments. The bipolar for-ceps are provided with bayonet-style handle design with straight or angled tips and different total lengths. They are to be connected through an appropriate bipolar cable with the bipolar output of an electrosurgical generator. The electrodes are provided sterile and are single-use instruments
Lot codes and dates
  • Models
    • 78 44 905 ST
    • 78 44 105 ST
    • 78 44 405 ST
    • 78 44 910 ST
    • 78 44 110 ST
    • 78 44 410 ST
    • 78 44 915 ST
    • 78 44 115 ST
    • 78 44 415 ST
    • 78 44 710 ST
    • 78 44 610 ST
    • 78 44 810 ST
    • 78 44 110 SL
    • 78 44 410 SL
    • 78 44 115 SL
    • 78 44 415 SL
Amount recalled
1337 units

Where it was sold

Why it was recalled

The label on the cardbox and the blister show the correct symbols for sterilization using irradiation and storage at 5 C to 40 C, the package insert (IFU) is labelled incorrectly. It shows the symbol for sterilization using Ethylene Oxide with the description for sterilization using irradiation.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 21, 2020 · Data as of Sep 19, 5:25 PM UTC

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