BD Pyxis Medication Dispensing Devices Labeling Update Addresses Manual Access Risk
FDA is requiring labeling updates for BD Pyxis automated medication dispensing devices to address the risk of delays in medication access due to power loss or device malfunctions. The recall affects approximately 1,521 units distributed nationwide.
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: Class II recall addressing potential delays in medication access from power loss or device malfunction. No injuries or illnesses reported. This qualifies as a risk-of-harm medical device without reported injury, meeting the High (3) severity criterion.
Plain-English summary
BD Pyxis MedFlex (REF 1119-00), MedBank Tower (REF 1145-00), and MedBank MedPass (REF 139088-01) automated medication dispensing devices, along with associated user guides and quick reference guides, are subject to a labeling update.
The FDA is requiring strengthened labeling regarding manual access to medications. The update addresses the risk of potential delays in retrieving or accessing medications that may result from power loss or automated dispensing device malfunctions.
Approximately 1,521 units have been distributed nationwide to healthcare facilities across the United States.
Healthcare facilities using these devices should review the updated labeling and user guides to understand manual medication access procedures in case of power loss or device malfunction.
The recalled product
- Product
- BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- medication-access-delay
- power-loss
- device-malfunction
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 (20)
- 13523350
- 13754724
- 13767953
- 13789575
- 13801727
- 13826187
- 13879544
- 13883357
- 13884848
- 13934472
- 13939327
- 13948724
- 14032802
- 14037891
- 14158187
- 14159916
- 14168580
- 14172832
- 14175162
- 14182716
Distribution
Distributed nationwide across the United States.
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