Alaris Pump Module Model 8100 — Class I medical device recall Z-2736-2020
Terminated recall by CareFusion 303, Inc., reported 2020-08-12, distributed in AK, AL, AR, AS, AZ, CA, CO, CT…. Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occ
| Recall number | Z-2736-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2020-06-30 |
| Classified | 2020-08-06 |
| Reported by FDA | 2020-08-12 |
| Terminated | 2024-04-23 |
| Distributed | AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Quantity | 1,093,588 |
| Model numbers | 8100 |
Product
Alaris Pump Module Model 8100
Reason for recall
Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane frame assembly. These may prevent devices from delivering accurate amounts of fluid, which may result in an over infusion, free-flow conditions, or under 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-2736-2020. 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.