Z-1694-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2024
- Initiation Date
- March 14, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10837
Product Description
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
Reason for Recall
Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.
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.
Code Information
UDI: 10888628043725 / Lot #: 23B35C, 23B41C, 23B42C, 23C05C, 23C06C, 23D01C, 24C12C