Recall Z-1206-2025— CareFusion 303, Inc.
Class II · Ongoing
Class II FDA medical device recall by CareFusion 303, Inc., initiated 2025-01-10. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions..
- Recalling firm
- CareFusion 303, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-10
- Firm location
- San Diego, CA, United States
Product description
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.
Reason for recall
Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions.
Data sourced from openFDA. This site is unofficial and independent of the FDA.