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U.S. Department of Health and Human Services

Class 2 Device Recall Sutter Swyng nonstick bipolar forceps, singleuse

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  Class 2 Device Recall Sutter Swyng nonstick bipolar forceps, singleuse see related information
Date Initiated by Firm June 23, 2020
Create Date July 31, 2020
Recall Status1 Open3, Classified
Recall Number Z-2744-2020
Recall Event ID 86035
510(K)Number K193587  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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.
Code Information 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 
Recalling Firm/
Sutter Medizintechnik GmbH
Tullastr. 87
Freiburg Im Breisgau Germany
For Additional Information Contact Reinhard Dichmann
Manufacturer 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.
FDA Determined
Cause 2
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 in Commerce 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = Sutter Medizintechnik GmbH