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BD Micro-Fine recallZ-1242-2023 · Becton Dickinson & Company · initiated Feb 1, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.

FDA root cause category: Under Investigation by firm

What the company is doing

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]

Recall details

Recall number
Z-1242-2023
Status
Open, Classified
Initiated by the company
Feb 1, 2023
Posted by the FDA
Mar 10, 2023
Recalling firm
Becton Dickinson & Company
Quantity
686,500 units
Product code
FMF
FDA submissions
K190054
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.

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

Code information (models, lots, serial numbers)

GTIN: (01) 00382903294619 Lot Number: 2031528, Exp. Date: 20270430

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 91495).

Sources and updates

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