Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
This recall is currently active, issued April 29, 2024. It was issued by Allergan Sales, Llc.
- Company
- Allergan Sales, Llc
- Recall Initiated
- March 14, 2024
- Posted
- April 29, 2024
- Recall Number
- Z-1694-2024
- Quantity
- 10837
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
UDI: 10888628043725 / Lot #: 23B35C, 23B41C, 23B42C, 23C05C, 23C06C, 23D01C, 24C12C
Root Cause
Process design
Action Taken
Between the dates of March 28, 2024 - April 1, 2024, Allergan Aesthetics (Allergan Sales LLC) issued a "Urgent Medical Device Recall" notification to affected consignees via FedEx. Allergan asked consignees to take the following actions: 1. If you have the affected product, discontinue further use and quarantine products prior to return. 2. Conduct a physical count of the affected product in your possession and record the count on the enclosed Business Response Form. 3. Send the Business Response Form to Qualanex LLC, AbbVie s third-party recall processor, via email within five (5) business days of receipt. To ensure we are able to account for all recalled product, it is imperative that you return the form. Please return the Business Response Form even if you have no recalled product to return. 4. Upon receipt of your Business Response Form, Qualanex LLC will issue a Return Authorization Form. When returning the recalled products, include the Return Authorization form and attach the prepaid Authorized Return shipping label to the outside of the return carton. Return the recalled product to: Qualanex, LLC 1410 Harris Rd. Libertyville, IL 60048 5. Please do not return any products that are not the subject of this recall. On 7/15/2025, updated recall notices were emailed to customers informing them of an additional impacted lot.