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FDA (Device enforcement)Recalled 2024-03-14class ii

Allergan Sales, LLC: Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,

Hazard

Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.

Details from the source

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: 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. Quantity: 10837 Lot/code info: UDI: 10888628043725 / Lot #: 23B35C, 23B41C, 23B42C, 23C05C, 23C06C, 23D01C, 24C12C

UPC codes

10888628043725

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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