Keller Funnel 2 breast implant insertion devices recalled for potential coating defect
Allergan recalls Keller Funnel 2 devices due to potential missing lubricating coating on breast implants, which may affect insertion. No injuries reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device where the potential defect (missing lubricating coating on implants) could compromise device function during insertion procedures. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a score of 3 (High).
Plain-English summary
Allergan Sales, LLC is recalling the Keller Funnel 2 (REF: HA-001), a medical device used to insert breast implants during surgical procedures. The recall is due to a potential defect where breast implants may lack the lubricating coating necessary for smooth insertion through the funnel.
The recall affects 10,837 units distributed nationwide throughout the United States. Affected lot numbers are: 23B35C, 23B41C, 23B42C, 23C05C, 23C06C, 23D01C, and 24C12C. This is a Class II recall by the FDA.
No illnesses or injuries have been reported in connection with this defect. Healthcare facilities and healthcare providers who have received affected units should contact Allergan Sales, LLC for instructions on replacement or further actions.
The recalled product
- Product
- Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
- Manufacturer
- Allergan Sales, LLC
- Hazard
- Affected units
- 10,837
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- UDI: 10888628043725 / Lot #: 23B35C
- 23B41C
- 23B42C
- 23C05C
- 23C06C
- 23D01C
- 24C12C
Distribution
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