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
Product summary
- 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
incorrectly labeled