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
FDA Recall Z-2424-2024 · Posted 2024-07-23
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Recalling FirmEmbecta Corp.
Recall StatusOpen, Classified
Product CodeFMI
Date Initiated2024-06-18
Product Quantity185900
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.
Firm 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: [email protected]
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: [email protected]
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).
Root Cause
Process control
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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