Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
Reported: May 8, 2024 Initiated: March 14, 2024 #Z-1694-2024
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.
Details
- Recalling Firm
- Allergan Sales, LLC
- Units Affected
- 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.
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,. Recalled by Allergan Sales, LLC. Units affected: 10837.
Why was this product recalled? ▼
Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 8, 2024. Severity: Moderate. Recall number: Z-1694-2024.
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