Reported May 8, 2024 · Ongoing

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

Allergan Sales, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Allergan Sales, LLC · 2525 Dupont Dr · Irvine, CA · 92612-1531

Is this the product you have?

  • Keller Funnel 2
  • REFHA-001, STERILEEO, Rx Only
Lot codes and dates
  • UDI
    • 10888628043725 / Lot #: 23B35C
    • 23B41C
    • 23B42C
    • 23C05C
    • 23C06C
    • 23D01C
    • 24C12C
Amount recalled
10837

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:58 PM UTC

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