Sutter Swyng non-stick bipolar forceps - Product Usage recall
Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments. The bipolar for-ceps are provided with…
Why was Sutter Swyng non-stick bipolar forceps - Product Usage 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical instruments. The bipolar for-ceps are provided with…
- Recalling firm
- Sutter Medizintechnik GmbH
- 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.
- Recall date
- August 12, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)