Device product
Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUCER Component: N/A
Z-0309-2026
Product summary
- Firm
- Aesculap Inc
- Event
- Event 97649
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 26 units
- Official record key
device-enforcement:Z-0309-2026
Official wording
Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Code information: Model No EK083P; UDI-DI: 04046963417710; Lots 52978946, 52991996, 53002275, 53004669, 53006807, 52941286, 52956527, 52956740, 52956952, 52957393, 52967167
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.