Z-1694-2024 Class II Ongoing
FDA device recall Z-1694-2024 was initiated by Allergan Sales, LLC on March 14, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 10837.
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2024
- Initiation Date
- March 14, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10837
Product Description
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
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 Pattern
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.
Code Information
UDI: 10888628043725 / Lot #: 23B35C, 23B41C, 23B42C, 23C05C, 23C06C, 23D01C, 24C12C