FDA recall Z-1694-2024

Allergan Sales, LLC · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2024-03-14
Report date
2024-05-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1694-2024