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Recall Observatory FDA recall evidence

Device product

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

Z-1694-2024

March 14, 2024

Class II

Product summary

Firm
Allergan Sales, LLC
Event
Event 94287
Status
Ongoing
Classification
Class II
Quantity
10837
Official record key
device-enforcement:Z-1694-2024

Official wording

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

Code information: UDI: 10888628043725 / Lot #: 23B35C, 23B41C, 23B42C, 23C05C, 23C06C, 23D01C, 24C12C

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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