Device product
Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description: SEALING CAP FOR 10/12MM TROCARS Component: N/A
Z-0310-2026
Product summary
- Firm
- Aesculap Inc
- Event
- Event 97649
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 140 units
- Official record key
device-enforcement:Z-0310-2026
Official wording
Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Code information: Model No EK085P; UDI-DI: 04046963620042; Lots 52987668, 52993442, 53001930, 53008562, 53013543, 52948710, 52954233, 52957528, 52966111, 52979586
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.