BD Pyxis MedStation ES AUX medication dispenser drawer and door failures
The BD Pyxis MedStation ES AUX medication dispenser may experience drawer and door failures due to latch, cable, or magnet defects, potentially delaying access to medications. Approximately 39,615 units are affected 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 an FDA Class II recall of a medical device that controls access to medications. No injuries or illnesses are reported in the source text, but the device failures create a risk of delayed medication access, which qualifies as a risk-of-harm product without reported injury per the rubric.
Plain-English summary
CareFusion 303, Inc. is recalling the BD Pyxis MedStation ES AUX (Reference 324) medication dispensing system. Approximately 39,615 units have been distributed worldwide.
Three failure mechanisms have been identified in affected units: door latch failure, cable ribbon damage, and magnet falling out. These defects may prevent the drawer or door from opening or closing properly.
These failures may lead to delays in accessing medications from the dispensing system. The U.S. Food and Drug Administration classified this as a Class II recall. Facilities using affected units should contact CareFusion 303, Inc. for information regarding device replacement or correction.
The recalled product
- Product
- BD Pyxis MedStation ES AUX, REF 324
- Manufacturer
- CareFusion 303, Inc.
- Hazard
- door-latch-failure
- cable-ribbon-damage
- magnet-failure
- medication-access-delay
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 10885403512681
- Serial Numbers: 9418071
- 9418110
- 9418124
- 9525533
- 9525534
- 9525559
- 9525563
- 9525583
- 9525601
- 9525603
- 9525604
- 9525607
- 9525614
- 9525615
- 9525616
- 9525617
- 9525618
- 9525629
- 9526868
Distribution
Distribution scope not specified by the agency.
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