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