BD Pyxis automated dispensing cabinets with noncertified power strips
BD Pyxis automated dispensing cabinets were shipped with socket-outlet power strips that lack IEC electrical certification, potentially exposing users to leakage currents and electric shock.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with a potential for harm from electrical leakage currents, including risk of permanent impairment. No illnesses or injuries have been reported, placing this in the 'High' category per the rubric's criteria for risk-of-harm products without reported harm.
Plain-English summary
BD Pyxis automated dispensing cabinets in multiple configurations were shipped with socket-outlet power strips. These power strips have not been certified to International Electrotechnical Commission (IEC) electrical standards for use as a system with the dispensing cabinet devices.
Approximately 3,002 affected units were manufactured between November 2012 and July 2023 and distributed nationwide across the United States. When operated with the noncertified power strips, users may be exposed to leakage currents.
Exposure to these leakage currents could result in varying degrees of harm, ranging from minor electric shock to permanent impairment. Healthcare facilities with affected BD Pyxis units should contact CareFusion 303, Inc. for information on remediation steps and proper certification of power supply components.
The recalled product
- Product
- BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 169-157, BD PYXIS MB TWR MN 1FM-10HH-1FH MP/ 169-143, BD PYXIS MB TWR MN 2FH-1FM-4HH-2FM MP/ 169-145, BD PYXIS MB TWR MN 2FM-8HH-1FH MP/ 169-144, BD PYXIS MB TWR
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- electrical-leakage
- electric-shock
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI-DI: 10885403512568. Devices Manufactured November 15
- 2012 - July
- 25 2023 User Guide
- DIR 10000414989/DIR 10000414987/DIR 10000414990
- Version 00.
Distribution
Distributed nationwide across the United States.
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