United StatesThe BD Alaris infusion Pump Module 8100 (REF 8100) and bezel assembly kits (REF 49000437 and REF 49000270) — all Alaris Pump Modules distributed after June 19, 2004 — are affected and can be identified by the listed REF/UDI‑DI numbers. They were recalled because dropping or severe jarring may damage the pump module bezel assembly, which can cause under‑infusion, over‑infusion, unregulated flow, or failure to calibrate. Dropped or severely jarred pumps should be removed from use and tested and inspected by qualified service personnel before reuse.
What's being recalled
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; Cleaning and Disinfecting Procedure, Part: P00000864; Cleaning and Disinfecting Quick Reference Guide
Recalling firm: CareFusion 303, Inc., San Diego, CA, United States.
How to identify it
All Alaris Pump Modules distributed after June 19, 2004. REF/UDI-DI: 8100/10885403810015, 10885403810046, 10885403810039, 10885403222054, 10885403517723, 10885403213212, 10885403211423; 49000437/10885403471018; 49000270/10885403247743
The hazard
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
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution. US nationwide including Puerto Rico, Guam, American Samoa, Northern Mariana Islands; and countries of SG, BH, AE, JP, CA, IT, QA, PH, DE, TW, PK, KR, BW, SA, MY, IL, NZ, AU, IN, GB, CN, NL, FR, ZA, BE, MX, CH, GI, KW, and TR.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada