Recall Z-1694-2024— Allergan Sales, LLC
Class II · Ongoing
Class II FDA medical device recall by Allergan Sales, LLC, initiated 2024-03-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,. Reason: Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure..
- Recalling firm
- Allergan Sales, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-14
- Firm location
- Irvine, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.