Alaris Infusion Pump Module — Class I medical device recall Z-1651-2021
Ongoing recall by The Biomed Guys, reported 2021-06-09, distributed in IN, TX. Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Mode
| Recall number | Z-1651-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Biomed Guys, Clarksville, TN, United States |
| Recall initiated | 2021-03-25 |
| Classified | 2021-06-01 |
| Reported by FDA | 2021-06-09 |
| Distributed | IN, TX |
| Quantity | 22 units |
| Reason classes | packaging |
| Model numbers | 8100, TIPA-8100-4410 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1651-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.