FDA-Device2012-08-29Class I
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
CareFusion 303, Inc.
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
Sold states
Worldwide Distribution-USA (nationwide) and the countries of Australia, European Union, and South Africa.
Affected count
43,862 units total (40,780 units in the US)
Manufactured in
10020 Pacific Mesa Blvd, N/A, San Diego, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2205-2012Don't want to check this manually?
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