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Recall Observatory FDA recall evidence

Device product

Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an impacted bezel repair part

Z-1544-2021

March 26, 2021

Class I

Product summary

Firm
Infusion Pump Repair
Event
Event 87657
Status
Ongoing
Classification
Class I
Quantity
15
Official record key
device-enforcement:Z-1544-2021

Official wording

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 information: 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 pattern: California

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.