Automated Medication Cabinet Recalled Due to Fingerprint Scanner Overheating Risk
CareFusion's BD Pyxis MedFlex automated medication cabinet is being recalled due to fingerprint scanner failure and overheating, posing a potential fire hazard in clinical settings.
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: FDA Class II recall of medical device with potential thermal hazard from scanner failure. No illnesses or injuries have been reported. This is a risk-of-harm product where injury has not yet been reported, meeting the Score 3 criterion.
Plain-English summary
CareFusion 303, Inc. is recalling the BD Pyxis MedFlex 2.0 automated dispensing cabinet (ADC) due to a defect in the fingerprint scanner component. The fingerprint scanner can fail and overheat, creating a potential safety hazard.
The recall involves 229 MedFlex units and 3,154 spare Bio-ID fingerprint scanner parts with specific serial/lot numbers. The affected products were distributed worldwide, including throughout the United States, Canada, Australia, and multiple other countries.
The BD Pyxis MedFlex is an automated medication dispensing system used in hospitals and clinical settings to store and dispense medications and supplies to authorized users. Facilities currently using affected cabinets should identify units by serial/lot number and contact the manufacturer for guidance.
Health care facilities should contact CareFusion 303, Inc. immediately for repair, replacement, or remediation instructions regarding affected equipment.
The recalled product
- Product
- BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated Dispensing Cabinet (ADC) intended to securely store and dispense medications and supplies to a qualified and authorized user in a clinical setting.
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- scanner-failure
- thermal-hazard
Distribution
Distributed nationwide across the United States.
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