BD PYXIS MEDBANK Medication Systems: Labeling Update for Operating Room Restriction
CareFusion is updating labeling for BD PYXIS MEDBANK medication systems to include a contraindication against use in procedure and operating rooms. Healthcare facilities should review updated labeling and ensure appropriate device placement.
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 medical device recall involving a labeling correction. The source explicitly states this is a labeling update with no reported incidents or injuries. The recall addresses a missing contraindication statement to prevent improper use, consistent with precautionary labeling updates.
Plain-English summary
CareFusion 303, Inc. is issuing a recall of multiple BD PYXIS MEDBANK medication dispensing systems distributed nationwide. The recall involves a labeling update that adds a contraindication statement against the use of these medicine cabinets in procedure and operating rooms.
The affected products include BD PYXIS MEDBANK MINI and MEDBANK TOWER models with various drawer configurations. These systems are distributed across all 50 states and Washington, D.C.
Healthcare facilities using these systems should review the updated labeling to understand the contraindication and ensure the medication cabinets are not used in procedure or operating room environments. Facilities may contact CareFusion 303, Inc. for updated labeling instructions or guidance on appropriate use locations.
No incidents or injuries related to this labeling issue have been reported.
The recalled product
- Product
- 155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MEDBANK MINI 1FH-2HH 138921-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 155159-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 169-101 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 139122-01 BD PYXIS MEDBANK MINI
- Manufacturer
- CareFusion 303, Inc.
- Hazard
Distribution
Part of a larger recall action
This product is one of 4 recalled by CareFusion 303, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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