Recall Z-1239-2023 ยท FMF Syringe, Piston
Becton Dickinson & Company
BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two Unit Scale- Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329424
| Date | Mar 10, 2023 (initiated Feb 1, 2023) |
| Status | Open, Classified |
| Reason | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection. |
| Root cause | Under Investigation by firm |
| Action | BD issued Urgent Medical Device Recall Letter to US Distributors/Wholesalers and Customer notification template on 2/1/23 via Federal Express (FedEx) and/or email, when available. OUS letters issued . Letter states reason for recall, health risk and action to take: 1. Immediately inspect your inventory for the specific catalog and lot number listed above. Destroy all affected products subject to the recall following your institution's process of destruction. 2. Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide |
| Quantity | 1,921,000 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190054 | BD Insulin Syringe Becton, Dickinson and Company, Oct 21, 2019 |