Recall Z-1244-2023
Becton Dickinson & Company · initiated February 1, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326725
Codes / lots: GTIN: N/A Lot Number: 2010670, Exp. Date:2031581 Lot Number: 2052365, Exp. Date:20270531
Reason for recall
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
FDA-determined cause: Under Investigation by firm
Action taken
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 a customer letter to all customers to advise them of this field action notification on BD's behalf. An example of a customer communication is attached for your reference. 3. Complete the attached Distributor Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product credit, if required Credit will be provided for all destroyed product following receipt of the completed Distributor Response Form. Contact: North American Regional Complaint Center Phone: 1-844-88D-LIFE (1-844-823-5433) Say "Recall" when prompted Mon-Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com
Details
- Recall number
- Z-1244-2023
- Initiated
- February 1, 2023
- Posted by FDA
- March 10, 2023
- Product code
- FMF – Syringe, Piston
- Quantity
- 1,472,400 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.
- Recalling firm
- Becton Dickinson & Company, Franklin Lakes, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1237-2023 Class II | BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed for…Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local… | 02/01/2023Open, Classified |
| Z-1238-2023 Class II | BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Single Unit…Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local… | 02/01/2023Open, Classified |
| Z-1239-2023 Class II | BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two Unit Scale-…Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local… | 02/01/2023Open, Classified |
| Z-1240-2023 Class II | BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed for…Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local… | 02/01/2023Open, Classified |
| Z-1241-2023 Class II | BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for…Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local… | 02/01/2023Open, Classified |
| Z-1242-2023 Class II | BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Single Unit…Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local… | 02/01/2023Open, Classified |
| Z-1243-2023 Class II | BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for…Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local… | 02/01/2023Open, Classified |