FDA Device recall Z-1543-2021
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
- FDA Device
- Class I
- terminated
- Published 2021-05-19
On 2021-05-19 the FDA classified a Class I recall of Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part by Step Har Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1543-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-02-26 |
| Published | 2021-05-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Step Har Medical |
| Distribution | IA |
Product
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
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.
Identifiers
| code_info | Serial Numbers: 12747983 and 9919591 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1543-2021%22
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