Aesculap Inc: Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Descriptio
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Aesculap Inc
- 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
- Reason / hazard
- It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2025-09-24
- Code info
- Model No EK085P; UDI-DI: 04046963620042; Lots 52987668, 52993442, 53001930, 53008562, 53013543, 52948710, 52954233, 52957528, 52966111, 52979586
- Product quantity
- 140 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Center Valley
- State
- PA
- Country
- United States
- Event id
- 97649
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