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CareFusion 303, Inc. recalls Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is inten
Recalled August 29, 2012 · FDA recall Z-2205-2012 · CareFusion 303
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 · FDA Class I
Units
43,862 units total (40,780 units in the US)
Sold at
Worldwide Distribution-USA (nationwide) and the countries of Australia, European Union, and South Africa.
Description
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
Product
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.
Manufacturer(s)
CareFusion 303, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →