Infusion Pump Repair: Medical Device Recall in 2021 - (Recall #: Z-1544-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: March 26, 2021

Date Posted: May 19, 2021

Recall Number: Z-1544-2021

Event ID: 87657

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.

Status: Ongoing

Product Quantity: 15

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

Voluntary or Mandated:

Voluntary: Firm initiated