Recall Z-1242-2023— 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 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. 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 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
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.