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