Recall Z-2744-2020— Sutter Medizintechnik GmbH
Class II · Terminated
Class II FDA medical device recall by Sutter Medizintechnik GmbH, initiated 2020-06-23, terminated 2020-08-21. It names one FDA 510(k) clearance: K193587. Product: 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.. 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..
- Recalling firm
- Sutter Medizintechnik GmbH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-23
- Terminated
- 2020-08-21
- Firm location
- Freiburg Im Breisgau, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.