Official recall record
BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. U
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-10-17
- Country of alert
- United States
- Alert level
- Class I
- Alert type
- recall
- Barcode (EAN/GTIN)
- 10885403810015
- Brand on record
- CareFusion 303, Inc.
- Product category
- Medical Device
What the authority reported
If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
All 11 official recall notices naming CareFusion 303, Inc. on this site →
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