BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lo
Summary
The FDA issued a Class II for BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Couns by Embecta Corp.. Reason: 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 an.
Details
Source
Device Recall
External ID
Z-2424-2024
Action Date
2024-07-31
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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.
Quantity Affected: 185900
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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-18
Company
Franklin Lakes, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Embecta Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Embecta Corp. have FDA actions?
This is the only FDA action we have on record for Embecta Corp. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2424-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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