(1) Pyxis MedStation ES recall: Software Issue
(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD…
Why was (1) Pyxis MedStation ES recalled?
Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
(1) Pyxis MedStation ES, Catalog No. 323, UDI-DI 10885403512667; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327, UDI-DI 10885403477836; (3) Pyxis MedStation ES Tower, Catalog No. 352, UDI-DI 10885403512674; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00, UDI-DI 10885403512605; All Serial Numbers; Software Versions v1.10 and prior Affected
- Product
- (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD…
- Recalling firm
- CareFusion 303, Inc.
- Quantity
- 137,741 total
- Distribution
- Domestic distribution nationwide. International distribution to North America, Latin America, EMEA, and Greater Asia.
- Recall date
- February 19, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)