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.
Enforcement
- Recall Number
- Z-2205-2012
- Event ID
- 62642
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- CareFusion 303, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 29, 2012
- Initiation Date
- June 15, 2012
- Classification Date
- August 17, 2012
- Termination Date
- May 13, 2014
- Address
- 10020 Pacific Mesa Blvd, N/A, San Diego, CA, 92121-4386, United States
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.
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
Model 8100; Lot/Serial numbers-various
Worldwide Distribution-USA (nationwide) and the countries of Australia, European Union, and South Africa.
43,862 units total (40,780 units in the US)