Reported Aug 22, 2012 · Terminated
Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize…
CareFusion 303, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CareFusion 303, Inc. · 10020 Pacific Mesa Blvd · San Diego, CA · 92121-4386
Is this the product you have?
- Alaris Pump Module model 8100
- Subsequent product codeFPA 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
- Lot codes and dates
- All serial numbers associated
- with the Alaris Pump Module Model 8100
8100 DEMO PUMP MODULE8100 Global Pump Module8100 IOC Pump Module V8.5.29.08100 LVP Training Unit8100 Pump Module V8.5.29.08100 Pump Module V8.5.29.0 (V9)Medley Patient Care System LVPModel 8100 Trade-In MaterialRCND 8100 Pump Module V8.5.29.0
- Amount recalled
- 102,248 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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