FDA-Device2024-05-08Class II
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
Allergan Sales, LLC
Hazard
Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.
Sold states
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.
Affected count
10837
Manufactured in
2525 Dupont Dr, Irvine, CA, United States
Products
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1694-2024Don't want to check this manually?
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