Z-1241-2023 Class II Ongoing
FDA device recall Z-1241-2023 was initiated by Becton Dickinson & Company on February 1, 2023 and is designated Class II. Reason for recall: Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. The recall status is ongoing. Affected quantity: 1,168,000 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 22, 2023
- Initiation Date
- February 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,168,000 units
Product Description
BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326678
Reason for Recall
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
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.
Code Information
GTIN: N/A Lot Number: 2045201, Exp. Date: 20270430; Lot Number: 2073801, Exp. Date: 20270531