Z-1543-2021 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 19, 2021
- Initiation Date
- February 26, 2021
- Termination Date
- August 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
Reason for Recall
Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.
Distribution Pattern
IA
Code Information
Serial Numbers: 12747983 and 9919591