Alaris Infusion Pump Module — Class I medical device recall Z-2204-2021
Terminated recall by BioMedical Equipment Service Co (BMES), reported 2021-08-18, distributed in CA, IL, IN, KY, LA, NJ, NV, OH…. Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may ov
| Recall number | Z-2204-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioMedical Equipment Service Co (BMES), Louisville, KY, United States |
| Recall initiated | 2021-02-25 |
| Classified | 2021-08-06 |
| Reported by FDA | 2021-08-18 |
| Terminated | 2024-04-22 |
| Distributed | CA, IL, IN, KY, LA, NJ, NV, OH, PA |
| Quantity | 718 potentially |
| Reason classes | packaging |
| Serial numbers | 10938662, 12328350, 12335127, 12356902, 12357956, 12371188, 12377005, 12377023, 12377451, 12377463, 12377486, 12377503, 12377633, 12377809, 12377870, 12378093, 12378095, 12378248, 12378293, 12378463, 12378686, 12379004, 12420646, 12421169, 12435805 and 475 more |
| Model numbers | 8100, TIPA-8100-4410 |
Product
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
Reason for recall
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.
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-2204-2021. 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.