FDAFDA · Food and drugs·Recall number Z-1694-2024
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
Published May 8, 2024 · Recall initiated: March 14, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Allergan Sales, LLC
- Distributor
- 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.
- Lot
- UDI: 10888628043725 / Lot #: 23B35C, 23B41C, 23B42C, 23C05C, 23C06C, 23D01C, 24C12C
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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