Class II

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

Allergan Sales, LLC · March 14, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

10837

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1694-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.