Z-0508-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 9, 2020
- Initiation Date
- October 23, 2020
- Termination Date
- September 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,881,200 units
Product Description
BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a cartridge contained in a drug pen injector Catalog Number: 320122
Reason for Recall
Product shelf cartons incorrectly labeled as products intended for the Latin American market. Although the product description on the label 32G x 4mm pen needles is correct, information pertinent to users in the US regarding compatibility with specific pen needles is missing.
Distribution Pattern
Nationwide
Code Information
Batch Number: 9352052 Exp. Date: 20241231