Allergan recalls Keller Funnel 2 devices (REF: HA-001) due to potential lack of lubricious coating causing breast implants to slip during implantation. Affected units have specific UDI and lot numbers.
Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.
Allergan is recalling Keller Funnel 2 devices used in breast implant procedures because they may lack a lubricious coating that allows implants to slide through the funnel during surgery. This could lead to implant misplacement if the funnel doesn't move smoothly.
The funnel may not have the required lubricious coating, which is necessary for breast implants to slide through during surgery. Without this coating, the implant could become stuck or mispositioned, potentially requiring additional surgical correction.
Medical professionals who use Keller Funnel 2 devices for breast implant procedures. Patients receiving implants through this funnel are at risk if the device fails to slide properly.
Check for the product name 'Keller Funnel 2', reference number HA-001, and sterile packaging. Affected units have specific UDI numbers: 10888628043725 and lot numbers 23B35C through 24C12C.
Verify the product name, reference number, and UDI on the device packaging.
The recall applies to devices used during implant procedures, not to patients who have already received implants.
Check the UDI and lot numbers on the device packaging to see if it is affected. If it is, contact Allergan for further instructions.
The device may cause breast implants to become stuck during surgery, requiring additional procedures. However, the risk is low and only applies to devices used in the implantation process.
We’ve drafted a message you can send Allergan to request your refund or repair — edit it as you like.
Subject: Recall Z-1694-2024 — Allergan Allergan Hello, I own a Allergan that is covered by recall Z-1694-2024 from Allergan. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
