BD PhaSeal Injector (Unknown) – Instructions Omission (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.

Recommended Action

Per FDA guidance

On 6/16/2025, Medical Device Product Advisory notices were mailed and emailed to customers who were asked to do the following: 1) The US IFU to be attached to your product can be accessed and downloaded from the following link by searching under the applicable product code: The US IFU to be attached to your product can be accessed and downloaded from the following link by searching under the applicable product code: eIFU.bd.com 2) Circulate this notice to all those who need to be aware within your organization or to any organization where the potentially affected products have been transferred. 3) Complete the attached Customer Response Form and return via email to BDRC13@bd.com Distributors were asked to do the following: Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this product advisory on recalling firm's behalf. Report any complaints experienced with the use of this product to firm via the North American Regional Complaint Center: Phone: 1-844-823-5433 Say "Product Complaints" when prompted Mon-Fri 8:00am to 5:00pm CT, Email: productcomplaints@bd.com