Recall Z-1694-2024 ยท KDD Kit, Surgical Instrument, Disposable
Allergan Sales, LLC
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
| Date | Apr 29, 2024 (initiated Mar 14, 2024) |
| Status | Open, Classified |
| Reason | Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure. |
| Root cause | Process design |
| Action | 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.