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Recall Observatory FDA recall evidence

Device product

BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Single Unit Scale-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329461

Z-1242-2023

February 01, 2023

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 91495
Status
Ongoing
Classification
Class II
Quantity
686,500 units
Official record key
device-enforcement:Z-1242-2023

Official wording

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

Code information: GTIN: (01) 00382903294619 Lot Number: 2031528, Exp. Date: 20270430

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.