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Recall Observatory FDA recall evidence

Device 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

Z-2424-2024

June 18, 2024

Class II

Product summary

Firm
Embecta Corp.
Event
Event 94851
Status
Ongoing
Classification
Class II
Quantity
185900
Official record key
device-enforcement:Z-2424-2024

Official wording

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 and integrity of the device cannot be guaranteed.

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.

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.