Recall StatusOpen, Classified
Date Initiated2023-02-01
Product Quantity1,921,000 units
Reason for Recall
Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.
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 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:
[email protected]
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.