FDA Device recall Z-1651-2021
Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris…
- FDA Device
- Class I
- ongoing
- Published 2021-06-09
On 2021-06-09 the FDA classified a Class I recall of Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris… by The Biomed Guys, citing 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.….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1651-2021 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-03-25 |
| Published | 2021-06-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | The Biomed Guys |
| Distribution | IN, TX |
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.
Reason
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.
Identifiers
| code_info | Serial numbers of serviced devices, serviced 09/2020-02-2021: 12833065, 13187021, 13187811, 12838069, 12982509, 128372…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1651-2021%22
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