BD PYXIS MEDBANK systems operating room contraindication labeling update
BD PYXIS MEDBANK medication management systems are subject to a labeling update adding a contraindication against use in procedure and operating rooms. Approximately 6,075 units were distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II device subject to a voluntary precautionary labeling update with no reported illnesses, injuries, or adverse events. The contraindication is being added to guide proper system placement and use in healthcare facilities.
Plain-English summary
BD PYXIS MEDBANK medication management systems (medicine cabinets) are the subject of a labeling update. The recalled units include various MEDBANK MINI, MEDBANK TOWER, MEDBANK MN 200, MEDBANK MN 500, MEDFLEX MN 1000, and MEDFLEX MN 2000 models manufactured by CareFusion 303, Inc. Approximately 6,075 units have been distributed nationwide throughout the United States.
The FDA is requiring manufacturers to update product labeling to include a contraindication statement. The updated labeling will specify that these medication management systems should not be used in procedure and operating rooms.
Healthcare facilities using these systems should obtain and review the updated labeling from the manufacturer. Ensure that PYXIS MEDBANK systems are not installed or used in procedure and operating room areas. Facilities should contact CareFusion 303, Inc. for updated labeling and guidance on proper system placement and use.
The recalled product
- Product
- 138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 BD PYXIS MEDBANK MINI CR-4HH-P 139001-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P 139002-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FM-P 139000-01 BD PYXIS
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- mis-labeling
- wrong-environment
Distribution
Distributed nationwide across the United States.
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