Recall Z-1240-2023— Becton Dickinson & Company
Class II · Ongoing
Class II FDA medical device recall by Becton Dickinson & Company, initiated 2023-02-01. It names one FDA 510(k) clearance: K190054. Product: BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326713. Reason: Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection..
- Recalling firm
- Becton Dickinson & Company
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-02-01
- Firm location
- Franklin Lakes, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326713
Reason for recall
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
Data sourced from openFDA. This site is unofficial and independent of the FDA.