BD PYXIS MEDBANK Medication Cabinet Software Issue Causes Incorrect Bin Labels
CareFusion is recalling BD PYXIS MEDBANK medication dispensing cabinets due to a software issue that causes incorrect bin information to print on restock labels, potentially leading to medication selection errors.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a Class II recall involving a risk-of-harm medical device (automated medication dispensing cabinet) where labeling errors could lead to medication selection errors. No illnesses or injuries have been reported in the source text.
Plain-English summary
CareFusion 303, Inc. is recalling BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P automated medication dispensing cabinets containing software version 3.9.1.9. The recall is due to a software defect that causes incorrect bin information to be printed on medication restock labels.
When pharmacy staff print a restock label for a medication stored in the cabinet, the label may indicate an incorrect bin location. This mislabeling could lead to staff selecting and dispensing the wrong medication during restocking operations.
Five units of the affected model have been distributed nationwide across the United States. Healthcare facilities using the affected equipment should contact CareFusion immediately for a software correction.
The recalled product
- Product
- BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software version 3.9.1.9
- Manufacturer
- CareFusion 303, Inc.
- Affected units
- 5
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 (1)
- UDI: 10885403512568/ Serial Number: 15940111 15967387 15775779 15598090 15561274
Distribution
Part of a larger recall action
This product is one of 19 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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