FDAFDA · Food and drugs·Recall number Z-2205-2012
Alaris Pump Module Model 8100 (formerly Medley Pump Module) 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.
Published August 29, 2012 · Recall initiated: June 15, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may separate from the keypad assembly
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CareFusion 303, Inc.
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of Australia, European Union, and South Africa.
- Lot
- Model 8100; Lot/Serial numbers-various
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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