FDA recall Z-1237-2023

Product

BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326679

Reason for recall

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

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2023-02-01

Report date

2023-03-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Franklin Lakes, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1237-2023