Model 8100 Series Medley Medication Safety System Pump… recallZ-0568-05 · Alaris Medical Systems Inc · initiated Nov 10, 2004
Terminated All recalls posted in March 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Alaris Medical Systems Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0568-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 10, 2004
- Posted by the FDA
- Mar 3, 2005
- Recalling firm
- Alaris Medical Systems Inc
- Quantity
- 55,200
- Product code
- FRN
- FDA submissions
- K950419, K012383
- Distribution
- United States and Canada
Product description
Model 8100 Series Medley Medication Safety System Pump Module
Code information (models, lots, serial numbers)
Serial Numbers 2326101 thru 9861567
Other devices under the same FDA submission
1 device cleared under K950419, K012383 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Alaris 8100Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths650,218 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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