FDA Enforcement
Class I
Ongoing
Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
Recall: Z-1544-2021
·
Reported May 19, 2021
Enforcement
- Recall Number
- Z-1544-2021
- Event ID
- 87657
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Infusion Pump Repair
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 19, 2021
- Initiation Date
- March 26, 2021
- Classification Date
- May 10, 2021
- Address
- 18 Technology Dr Ste 133, Irvine, CA, 92618-2311, United States
Description
Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
Reason
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.
Code Info
Devices distributed between 01/15/2021 and 03/14/2021. Sale Order #/Serial #: 1599930872/ 12335834, 13617863, 13447266, 13089105, 12333728, 13616451, 13618575, 12729374; 82943/ 4122252, 4122320; 01112101A/ 12638236, 13813590, 12639090, 13744738, 9951014
Distribution
California
Quantity
15