Z-1651-2021Class I

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

Name: Z-1651-2021 Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair...
Creator: The Biomed Guys
Published: 2021-03-25
License: https://open.fda.gov/license/

The Biomed Guys / initiated 2021-03-25 / Open, Classified / root cause: manufacturing process

FDA source

The Biomed Guys began a recall of Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel on 2021-03-25. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1651-2021
Classification: Class I
Status: Open, Classified
Initiated: 2021-03-25
Posted: 2021-06-01
Recalling firm: The Biomed Guys
Product: 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 code: FRN Pump, Infusion
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: The firm notified their consignees via email 3/25/2021 and multiple phone calls 3/25/2021, 3/26/2021 & 3/30/2021. Customers where also sent empty boxes with packing material to return their affected devices for inspection and remediation.
Quantity in commerce: 22 units
Distribution: Us distribution to the states of IN and TX.
Product codes and lots: 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,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1651-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1651-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-06-09	2021-06-01

Product code FRN

K133532Class IIAlaris System with Guardrails Suite MxCarefusion 303, Inc. / cleared 2014-08-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)