Infusion Pump Repair Recall 87657
Description: Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part
Infusion Pump Repair Recall 87657 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1544-2021 |
Event ID | 87657 |
Event Description | Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part |
Product Type | Devices |
Distribution | California |
Quantity | 15 |
Recall 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. |
Device Classification | 20210519 |
Device 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 |
Center Classification Date | 20210510 |
Recall Initiation Date | 20210326 |
Recalling Firm | Infusion Pump Repair |
Initial Notification | Letter |
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