FDA Device

Model 8100 Series Medley Medication Safety System Pump Module

Hazard

The device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module. To date there have been complaints from three (3) different customer locations.

What You Should Do

Remedy

A device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module.

Products

Model 8100 Series Medley Medication Safety System Pump Module
Brand
Alaris Medical Systems Inc
UPC
Serial Numbers 2326101 thru 9861567

Units Affected

55,200