BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Py

FDA device recall Z-1050-2025 · posted 2025-01-30 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

Due to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory discrepancies, a delay in access to medication and/or diversion of medication.

Action taken

On 02/14/2023 and 01/09/2024, the firm sent an "Urgent Medical Product Advisory" letter to customers informing them that BD was made aware due to an increase in customer complaints for AUX Tower Door Latch assembly failures. The latch failure can leave the door in an open state, potentially causing inventory discrepancies (including billing), a delay in access to medication and/or diversion of medication. Customers were instructed: 1. May continue to use these devices as intended and should file a complaint via the Customer Portal at https://www.bd.com/self-service or call BD Support at 1-800-727-6102, should you experience drawer or door failures. 2. If customers experience delays in access to medication due to a drawer or door failure, ensure backup procedures (which may include but may not necessarily be limited to keys, emergency medication supplies, alternate devices in proximity, etc.) are in place and staff have all been properly trained on them. 3. Promptly complete and return the enclosed Customer Response Form to acknowledge receipt of this notification and that you understand the information provided in this letter. For Distributors: 1. Provide a copy of this notification to any customers who may have received products listed in the Affected Products table above. 2. Promptly complete and return the enclosed Customer Response Form to acknowledge receipt of this notification and that you understand the information provided in this letter. For questions - contact 1-866-583-8783 Actions Taken by BD for Door Latch Failure: 1. Revised BD Pyxis Field Service Guide to include the use of a conductive contact enhancer that will help prevent corrosion and increase connectivity to the latch thus significantly reducing door failures. 2. Updating the door latch design. 3. If Auxiliary Tower Door failure occurs due to poor connection, BD will provide service support to evaluate and resolve the issue.

Root cause

Device Design

Status

Open, Classified

Product code

BRY

Quantity affected

Initial: 27,666 Expansion: 5,923 = 33,589 systems

Distribution

U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA

Date initiated

2023-02-14

Date posted

2025-01-30

Location

San Diego, CA