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Recall Observatory FDA recall evidence

Device product

BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326725

Z-1244-2023

February 01, 2023

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 91495
Status
Ongoing
Classification
Class II
Quantity
1,472,400 units
Official record key
device-enforcement:Z-1244-2023

Official wording

Reason: Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.

Code information: GTIN: N/A Lot Number: 2010670, Exp. Date:2031581 Lot Number: 2052365, Exp. Date:20270531

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Chile, Colombia, Dominican Republic, Bahamas, Panama, Peru, Mexico, El Salvador, Mexico, Malaysia, Philippines, Vietnam, Hong Kong, Taiwan, Thailand, Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.