Z-0568-05

Model 8100 Series Medley Medication Safety System Pump Module

Name: Z-0568-05 Model 8100 Series Medley Medication Safety System Pump Module
Creator: Alaris Medical Systems Inc
Published: 2004-11-10
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2004-11-10 / Terminated

FDA source

Alaris Medical Systems Inc began a recall of Model 8100 Series Medley Medication Safety System Pump Module on 2004-11-10. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0568-05
Status: Terminated
Initiated: 2004-11-10
Posted: 2005-03-03
Terminated: 2005-09-02
Recalling firm: CareFusion 303, Inc
Product: Model 8100 Series Medley Medication Safety System Pump Module
Product code: FRN Pump, Infusion
Reason for recall: 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.
FDA root cause: Other
Action: 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.
Quantity in commerce: 55,200
Distribution: United States and Canada
Product codes and lots: Serial Numbers 2326101 thru 9861567

Product code FRN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)