(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES T

FDA device recall Z-1119-2025 · posted 2025-02-07 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues

Action taken

On January 8, 2025, the firm notified customers via email and mailed letter titled "Urgent Medical Device Correction". Firm states customers can continue to use Pyxis products in accordance with their labeling and any previously provided field action notifications, including the following guidance: 1. Facilities should establish policies and procedures for when an automated dispensing system is unavailable. 2. Device Keys can manually access unavailable drawers, but must be readily available and retrievable to adequately mitigate the risk. 3. Emergency supplies should be physically available in care areas for critical or urgent medications. 4. If using critical override mode to access contents of the device, users must use extra precautions and verify correct medications are selected. The firm anticipates releasing software update ES 1.11 beginning June 2025, which will address these software issues.

Root cause

Software design

Status

Open, Classified

Product code

BRY

Quantity affected

137,741 total

Distribution

Domestic distribution nationwide. International distribution to North America, Latin America, EMEA, and Greater Asia.

Date initiated

2025-01-08

Date posted

2025-02-07

Location

San Diego, CA