The Biomed Guys: Medical Device Recall in 2021 - (Recall #: Z-1651-2021)

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 Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.

Product Classification:

Class I

Date Initiated: March 25, 2021

Date Posted: June 9, 2021

Recall Number: Z-1651-2021

Event ID: 87768

Reason for Recall:

Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.

Status: Ongoing

Product Quantity: 22 units

Code Information:

Serial numbers of serviced devices, serviced 09/2020-02-2021: 12833065, 13187021, 13187811, 12838069, 12982509, 12837231, 12835186, 12837972, 12710593, 12776790, 13753893, 13605919, 12832544, 15763526, 14806203, 14806612, 14807070, 13738432, 15763547, 15865626, 14806472, 12796415,

Distribution Pattern:

Us distribution to the states of IN and TX.

Voluntary or Mandated:

Voluntary: Firm initiated