BD Pyxis MedStation 4000 Medication Dispenser Recalled for Door Failures
BD Pyxis MedStation 4000 medication dispensers are recalled due to drawer and door failures that may delay medication access. The recall affects 13,055 units distributed worldwide.
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: This is a Class II FDA recall of a risk-of-harm product (medication dispensing system) with no reported illnesses or injuries. Mechanical failures that delay access to medications in healthcare settings present potential for significant patient harm.
Plain-English summary
BD Pyxis MedStation 4000 Main medication dispensers have been recalled due to drawer and/or door failures. The device is a medication dispensing system manufactured by CareFusion 303, Inc.
The recall involves three identified failure modes: door latch failure, cable ribbon damage, and magnet falling out. These failures may lead to a delay in access to medications. The recall affects 13,055 units distributed worldwide.
The FDA classified this as a Class II recall. Healthcare facilities and medication management personnel using affected units should be aware of the potential for these mechanical failures.
The recalled product
- Product
- BD Pyxis MedStation 4000 Main, REF 303
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- door-latch-failure
- cable-ribbon-damage
- magnet-falling-out
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)
- UDI/DI 10885403512629
- Serial Numbers: 12439536
- 12439538
- 12439539
- 12439540
- 12439541
- 12439544
- 12440786
- 12440787
- 12440788
- 12440789
- 12440790
- 12440791
- 12440792
- 12440978
- 12440979
- 12441431
- 12443165
- 12446066
- 12448071
Distribution
Distribution scope not specified by the agency.
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