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

Recall date

June 23, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2744-2020

FDA classification

Class II

Brand / firm

Sutter Medizintechnik GmbH

Sold / distributed

US Nationwide distribution including in the states of MD, NJ, MI, NC, IN, CA, AL, WA, OK, MS, GA, FL, SC, TX, CO, MN, MO, KS.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Sutter Swyng non-stick bipolar forceps - Product Usage: single-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.