Physician Order Form — Class II medical device recall Z-1996-2021
Terminated recall by Flowonix Medical Inc, reported 2021-07-07, distributed nationwide. Physician Order Form (PL-15400-00 Nov 2018) distributed is discontinued due to the text 'Refill the pump and p
| Recall number | Z-1996-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Flowonix Medical Inc, Mansfield, MA, United States |
| Recall initiated | 2021-05-26 |
| Classified | 2021-07-01 |
| Reported by FDA | 2021-07-07 |
| Terminated | 2024-02-20 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00810335020082, 00810335020228, 00810335020242 |
| Model numbers | 11827, GTIN-14 |
Product
Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable Infusion Pump System: MODEL/CATALOG #(s): Catalog No. US Model GTIN-14 11827 Prometra Programmable 20mL Pump 00810335020082 13827 Prometra II Programmable 20mLPump 00810335020228 16827 Prometra II Programmable 40mLPump 00810335020242
Reason for recall
Physician Order Form (PL-15400-00 Nov 2018) distributed is discontinued due to the text 'Refill the pump and program refill with the same medication removed prior to MRI' may be misinterpreted as 'reuse the same drug solution extracted from the pump prior to the MRI procedure', creating a possible risk of infection
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-1996-2021. 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.