Enteral Infusion Pump — Class II medical device recall Z-1347-2021
Completed recall by Cardinal Health 200, LLC, reported 2021-04-14, distributed nationwide. The potential for air appearing in the enteral feed pumping set tubing during set-up.
| Recall number | Z-1347-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2021-01-19 |
| Classified | 2021-04-02 |
| Reported by FDA | 2021-04-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, CA, CH, CL, CO, JP, MX, NL, PA, PE, SG, TR |
| Quantity | 146,944,334 units |
| Model numbers | 612054, 613650, 614650, 672055, 673656, 673662, 674655, 674668, 674669, 716154, 762055, 763656, 763662, 765100, 765559, 772055, 773656, 773662, 775100, 775659, 776150 |
Product
Enteral Infusion Pump
Reason for recall
The potential for air appearing in the enteral feed pumping set tubing during set-up.
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-1347-2021. 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.