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 ST78 44 105 ST78 44 405 ST78 44 910 ST78 44 110 ST78 44 410 ST78 44 915 ST78 44 115 ST78 44 415 ST78 44 710 ST78 44 610 ST78 44 810 ST78 44 110 SL78 44 410 SL78 44 115 SL78 44 415 SL
- Models
- 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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