BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Single Unit Scale-Insulin Syringes are designed
FDA device recall Z-1242-2023 · posted 2023-03-10 · Open, Classified
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
- 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
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FMF
- Quantity affected
- 686,500 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,
- Date initiated
- 2023-02-01
- Date posted
- 2023-03-10
- Location
- Franklin Lakes, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD Insulin Syringe (K190054) | Becton, Dickinson and Company | 2019-10-21 |