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U.S. Department of Health and Human Services

Class 2 Device Recall Keller Funnel 2

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  Class 2 Device Recall Keller Funnel 2 see related information
Date Initiated by Firm March 14, 2024
Date Posted April 29, 2024
Recall Status1 Open3, Classified
Recall Number Z-1694-2024
Recall Event ID 94287
Product Classification unknown device name - Product Code N/A
Product Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
Code Information UDI: 10888628043725 / Lot #: 23B35C, 23B41C, 23B42C, 23C05C, 23C06C, 23D01C
Recalling Firm/
Manufacturer		 Allergan Sales, LLC
2525 Dupont Dr
Irvine CA 92612-1531
For Additional Information Contact Nicole Katz
714-246-4500
Manufacturer 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.
FDA Determined
Cause 2		 Process design
Action Between the dates of March 28, 2024 - April 1, 2024, Allergan Aesthetics (Allergan Sales LLC) issued a "Urgent Medical Device Recall" notification to affected consignees via FedEx. Allergan asked consignees to take the following actions: 1. If you have the affected product, discontinue further use and quarantine products prior to return. 2. Conduct a physical count of the affected product in your possession and record the count on the enclosed Business Response Form. 3. Send the Business Response Form to Qualanex LLC, AbbVie s third-party recall processor, via email within five (5) business days of receipt. To ensure we are able to account for all recalled product, it is imperative that you return the form. Please return the Business Response Form even if you have no recalled product to return. 4. Upon receipt of your Business Response Form, Qualanex LLC will issue a Return Authorization Form. When returning the recalled products, include the Return Authorization form and attach the prepaid Authorized Return shipping label to the outside of the return carton. Return the recalled product to: Qualanex, LLC 1410 Harris Rd. Libertyville, IL 60048 5. Please do not return any products that are not the subject of this recall.
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.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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