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

Recall date

March 14, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1694-2024

FDA classification

Class II

Brand / firm

Allergan Sales, LLC

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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