[pending] BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY O
Pending LLM rewrite. Source: FDA_DEVICE Z-0430-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Clean
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Devices
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 (10)
- All Alaris Pump Modules distributed after June 19
- 2004. REF/UDI-DI: 8100/10885403810015
- 10885403810046
- 10885403810039
- 10885403222054
- 10885403517723
- 10885403213212
- 10885403211423
- 49000437/10885403471018
- 49000270/10885403247743
Distribution
Distributed nationwide across the United States.
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