Infusion pump modules recalled because drops can damage the bezel assembly

Plain-English summary

The BD Alaris Infusion Pump Module 8100, REF 8100, along with the bezel assembly kits REF 49000437 and REF 49000270, is being recalled, together with new and updated documents including an Inspection Safety Reminder.

If the 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 failure of the pump module to calibrate. The firm states that dropped or jarred pumps should be removed from use, tested and inspected by qualified service personnel before reuse, and that the tip sheet, cleaning and disinfecting procedure and reference guide have been updated.

The recall covers 2,574,396 units, comprising all Alaris Pump Modules distributed after 19 June 2004. Distribution was worldwide, including nationwide in the United States and to Puerto Rico, Guam, American Samoa and the Northern Mariana Islands. The FDA has classified the recall as Class I, its most serious category.

Facilities should follow BD's inspection instructions and remove any dropped or jarred module from service until it has been checked.

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 — Infusion pump

Hazard

• bezel-damage
• over-infusion
• under-infusion
• class-i
• unregulated-flow

Affected units

2,574,396

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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