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Recall Observatory FDA recall evidence

Device product

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

Z-0508-2021

October 23, 2020

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 86679
Status
Terminated
Classification
Class II
Quantity
2,881,200 units
Official record key
device-enforcement:Z-0508-2021

Official wording

Reason: 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.

Code information: Batch Number: 9352052 Exp. Date: 20241231

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrectly labeled