BD Pyxis" Anesthesia Station ES, REF: 327

FDA device recall Z-1931-2024 · posted 2024-05-30 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

Action taken

On May 2, 2024, CareFusion, a subsidiary of Becton, Dickinson and company issued a "Urgent Medical Device Correction", to affected consignees. On September 30, 2025, BD issue a Urgent Medical Device Recall Expansion notification to affected consignees via FedEx. BD is asking consignees to take the following actions: 1. Affected products can continue to be used per existing Manuals and Guides. 2. In the event of an accidental fluid spill on the device or in a drawer, users should following instructions outlined within the customer notification. 3. Review the customer letter attachment which provides warnings, cautions and recommendations regarding fluid ingress. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material.

Root cause

Component design/selection

Status

Open, Classified

Product code

BRY

Quantity affected

71,569 units

Distribution

Worldwide - US Nationwide distribution including in the states of 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

Date initiated

2024-04-15

Date posted

2024-05-30

Location

San Diego, CA