Summary
The FDA issued a Class II for Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only, by Allergan Sales, LLC. Reason: Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.
Details
Source
Device Recall
External ID
Z-1694-2024
Action Date
2024-05-08
Status
Ongoing
Category
device
Product Description
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
Lot/Code Info: UDI: 10888628043725 / Lot #: 23B35C, 23B41C, 23B42C, 23C05C, 23C06C, 23D01C, 24C12C
Quantity Affected: 10837
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-14
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 175 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Allergan Sales, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Allergan Sales, LLC have FDA actions?
This is the only FDA action we have on record for Allergan Sales, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1694-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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