Alaris Medical Systems Inc Model 8100 Series Medley Medication Safety System Pump Module Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Model 8100 Series Medley Medication Safety System Pump Module
Brand
Alaris Medical Systems Inc
Lot Codes / Batch Numbers
Serial Numbers 2326101 thru 9861567
Products Sold
Serial Numbers 2326101 thru 9861567
Alaris Medical Systems Inc is recalling Model 8100 Series Medley Medication Safety System Pump Module due to The device modification is being implemented in response to information received from the field regarding a specific method of misloading the medicati. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026