Device product
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
Z-1694-2024
Product summary
- Event
- Event 94287
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10837
- Official record key
device-enforcement:Z-1694-2024
Official wording
Reason: Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.
Code information: UDI: 10888628043725 / Lot #: 23B35C, 23B41C, 23B42C, 23C05C, 23C06C, 23D01C, 24C12C
Distribution pattern: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
Derived failure modes
-
Unknown
Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.