FDA Enforcement Class II Ongoing

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

Recall: Z-2424-2024 · Reported July 31, 2024

Enforcement

Recall Number
Z-2424-2024
Event ID
94851
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
Embecta Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
July 31, 2024
Initiation Date
June 18, 2024
Classification Date
July 23, 2024
Address
1 Becton Dr Mc 355, Franklin Lakes, NJ, 07417-1815, United States

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

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 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.

Distribution

US Nationwide distribution.

Quantity

185900