BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lo
FDA device recall Z-2424-2024 · posted 2024-07-23 · Open, Classified
Recall details
- Recalling firm
- Embecta Corp.
- 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.
- Action taken
- 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).
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FMI
- Quantity affected
- 185900
- Distribution
- US Nationwide distribution.
- Date initiated
- 2024-06-18
- Date posted
- 2024-07-23
- Location
- Franklin Lakes, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD Nano 2nd Gen Pen Needle (K212015) | Becton, Dickinson and Company | 2021-11-19 |