Class 2 Device Recall BD Nano 2nd Gen Pen Needles

• Date Initiated by Firm: June 18, 2024
• Date Posted: July 23, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2424-2024
• Recall Event ID: 94851
• 510(K)Number: K212015
• Product Classification: Needle, hypodermic, single lumen - Product Code FMI
• Product: BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use devices designed for the parenteral administration of a drug from a cartridge contained in a drug pen injector Model/Catalog Number: 320551
• Code Information: GTIN: (01)10382903205513 Lot Number: 9044773 Expiry Date: 2024/02/29 *The Patient Counseling Sample Toolbox contains BD Nano" 2nd Gen Pen Needles and patient brochures, it has a marketing reference number of 6484755 and lot 3750144.
• FEI Number: 3022699058
• Recalling Firm/ Manufacturer: Embecta Corp.; 1 Becton Dr Mc 355; Franklin Lakes NJ 07417-1815
• Manufacturer Reason for Recall: BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February 29, 2024. Using a device past its expiry sterility and integrity of the device cannot be guaranteed.
• FDA Determined Cause: Process control
• Action: embecta* issued Urgent Medical Device Recall Letter on 6/18/24 via Fed'X to Pharmacist & Pharmacy Staff and End Users. Letter states reason for recall, health risk and action to take: 1. Review your product to see if it matches the specific Catalog (Ref) and Lot number listed above. Immediately discard all unused product into a sharps container. 2. If the affected product was previously used, follow up with a healthcare professional if there are any adverse reactions such as inflammation or redness of the skin. 3. Complete the online Customer Response Form whether or not you have any of the impacted materials so we may acknowledge your receipt of this notification: https://iqvia-response.my.site.com/mt/fca?cid=embc240004. Report any adverse health consequences experienced with the use of this product to embecta. If you require further assistance, please contact: Support US Contact Information Areas of Support Recall response support Phone: +1 650 540 3359 Mon-Fri 8:00am-5PM PST Email: embc-24-0004@iqvia.com Recall questions, customer response form, and product returns North American Customer Care Phone: 888-232-2737 Say Recall when prompted Mon Fri 8:30am-5:00pm EST Email: diabetes@embecta.com Product Complaints, Technical Questions *On April 1, 2022, BD completed the spinoff of its global diabetes care business into a separate, newly established company, Embecta Corp (embecta).
• Quantity in Commerce: 185900
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

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.

• 510(K) Database: 510(K)s with Product Code = FMI