Recall of BD Pyxis Medflex MN 1000 and 2000 models for labeling update to include contraindication against use in procedure and operating rooms.
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
CareFusion recalls specific BD Pyxis Medflex MN 1000 and 2000 models due to a labeling update required to include a contraindication statement against using these devices in procedures and operating rooms. This update is necessary to ensure safe use in medical settings.
The hazard involves a labeling update to include a contraindication statement against using these devices in procedures and operating rooms. This means the devices are not intended for use in those settings without proper labeling, which could lead to unsafe practices if misused.
Healthcare professionals and facilities that own or use the recalled BD Pyxis Medflex MN 1000 and 2000 models. Patients are not directly affected as the issue is a labeling update for safe use in procedures.
Check for the specific model numbers listed in the recall, such as BD PYXIS MEDFLEX MN 1000 10HH-1FM, BD PYXIS MEDFLEX MN 1000 12HH, and BD PYXIS MEDFLEX MN 2000 10HH-1FM. These models were sold with the outdated labeling that does not include the required contraindication statement.
Review the device's labeling for the contraindication statement against use in procedures and operating rooms.
The recall is for a labeling update to include a contraindication statement against using these devices in procedures and operating rooms.
No, the recall does not require stopping use. The issue is a labeling update to ensure safe use in procedures and operating rooms.
Check the labeling for the contraindication statement. If the labeling does not include this statement, contact CareFusion for guidance.
We’ve drafted a message you can send BD Pyxis to request your refund or repair — edit it as you like.
Subject: Recall Z-1229-2025 — BD Pyxis BD Pyxis Hello, I own a BD Pyxis that is covered by recall Z-1229-2025 from BD Pyxis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
