Device product
Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALING UNIT FOR 10/12MM TROCARS Component: N/A
Z-0311-2026
Product summary
- Firm
- Aesculap Inc
- Event
- Event 97649
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 26 units
- Official record key
device-enforcement:Z-0311-2026
Official wording
Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Code information: Model No EK086P; UDI-DI: 04046963425272; Lots 52968398, 52975386, 52988022, 52993532, 53008999, 53009000, 53009001, 53009417
Distribution pattern: Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, MD, NE, NM, NY, OR, PA, WA, WI and the country of Canada.
Derived failure modes
-
Unknown
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.