FDAClass IIMay 8, 2024

Keller Funnel 2 recall

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

Why was Keller Funnel 2 recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
Recalling firm
Allergan Sales, LLC
Quantity
10837
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.
Recall date
May 8, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls