Recall Z-2744-2020 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Sutter Medizintechnik GmbH
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 in
| Date | Jun 23, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling design |
| Action | Sutter Medizintechnik issues a recall letter via email dated July 2020. This letter instructs customers/distributors to do the following: Please further notify anyone you have distributed the product to. Please complete and return the acknowledgement and receipt form. Please exchange the IFU inside the package. You may follow the instruction as shown in the pictures. As a precautionary measure, do NOT use sharp tools such as forceps and do not perform the exchange with sharp fingernails. |
| Quantity | 1337 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193587 | Sutter Swyng non-stick bipolar forceps, single-use Sutter Medizintechnik GmbH, Feb 10, 2020 |