Alaris Pump Module model 8100 recallZ-2185-2012 · CareFusion 303, Inc. · initiated Jun 29, 2012
Class I Terminated All recalls posted in August 2012
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 CareFusion 303, 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 recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module model 8100. Carefusion has received reports of customers experiencing motor stalls during infusion with Alaris Pump Module (model 8100) manufactured between August 2010 and July 2011.
FDA root cause category: Under Investigation by firm
What the company is doing
CareFusion sent an Urgent Medical Device Recall Notification letter dated July 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Required action for users instructed high risk patients undergoing infusions at high rates, consider having additional devices as back up. Clinicians should weigh the risk/benefit to the patients before continuing to use the device. Customers with recall related questions were instructed to contact Carefusion support center at (888) 562-6018. Customers with adverse event report questions were instructed to contact customer advocacy at (800) 854-7128, option 1, option 1, option 3 or email at [email protected]. Customers with technical questions regarding the Alaris system were instructed to contact Technical support at (888) 812-3229. For questions regarding this recall call 858-617-4000.
Recall details
- Recall number
- Z-2185-2012
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Jun 29, 2012
- Posted by the FDA
- Aug 15, 2012
- Recalling firm
- CareFusion 303, Inc.
- Quantity
- 102,248 units
- Product code
- FRN
- FDA submissions
- K950419
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of: South Africa and Canada. Additional Countries: Netherlands.
Product description
Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.
Code information (models, lots, serial numbers)
All serial numbers associated with the Alaris Pump Module Model 8100: 8100 DEMO PUMP MODULE; 8100 Global Pump Module; 8100 IOC Pump Module V8.5.29.0; 8100 LVP Training Unit; 8100 Pump Module V8.5.29.0; 8100 Pump Module V8.5.29.0 (V9); Medley Patient Care System LVP; Model 8100 Trade-In Material; RCND 8100 Pump Module V8.5.29.0
Other devices under the same FDA submission
1 device cleared under K950419 — 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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