Medication dispensing cabinets recalled after reports of delayed access during override workflow
BD is recalling 6,076 Pyxis MedBank and MedBank Mini automated dispensing cabinets after reports of delayed access to medication caused by the override and Add Item workflow.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
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: The rubric puts FDA Class III actions at 1 or 2, and the reported consequence is delayed access to medication rather than a device failure causing harm.
Plain-English summary
BD Pyxis MedBank and MedBank Mini automated dispensing cabinets are being recalled, covering configurations including REF 169-137, 169-113, 169-112, 169-111, 169-110, 169-109, 169-108, 169-107 and 169-106, with UDI-DI numbers including 10885403512544, 10885403517181, 10885403512568, 10885403517167 and 10885403512704. The recall covers 6,076 units distributed nationwide across all fifty states and the District of Columbia.
The recall follows reports of delayed access to medication in the automated dispensing cabinets because of the override and Add Item workflow. The FDA classified the action as Class III.
Hospital pharmacies operating these cabinets should check the REF and serial numbers against the recall notice and follow the manufacturer's instructions, which BD is issuing to affected customers.
The recalled product
- Product
- Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS MEDBANK MINI 3HH-1HM/169-111, BD PYXIS MEDBANK MINI 3HH-1FG/169-110, BD PYXIS MEDBANK MINI 2HM-1FM/169-109, BD PYXIS MEDBANK MINI…
- Manufacturer
- CareFusion 303, Inc.
- Affected units
- 6,076
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 (4)
- UDI-DI: 10885403512544
- 10885403517181
- 10885403512568
- 10885403517167
Distribution
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