Recall Z-1050-2025— CareFusion 303, Inc.

Class II · Ongoing

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2023-02-14. FDA's recall record names no specific 510(k) clearance for this event. Product: BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely store and dispense medications to a qualified and authorized healthcare provider.. Reason: 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..

Recalling firm
CareFusion 303, Inc.
Classification
Class II
Status
Ongoing
Initiated
2023-02-14
Firm location
San Diego, CA, United States

Product description

BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely store and dispense medications to a qualified and authorized healthcare provider.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.