PlainRecalls
FDA Devices Critical Class I Terminated

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

Reported: August 29, 2012 Initiated: June 15, 2012 #Z-2205-2012

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
CareFusion 303, Inc.
Units Affected
43,862 units total (40,780 units in the US)
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Australia, European Union, and South Africa.
Location
San Diego, CA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by CareFusion 303, Inc.. Units affected: 43,862 units total (40,780 units in the US).
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 29, 2012. Severity: Critical. Recall number: Z-2205-2012.

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