Reported Jul 7, 2021 · Terminated
Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following
Flowonix Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Flowonix Medical Inc · 120 Forbes Blvd Ste 170 · Mansfield, MA · 02048-1150
Is this the product you have?
Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following
4 of 4 products
| Model / number | Product as published |
|---|---|
GTIN-14 | Model |
00810335020082 | Programmable 20mL Pump |
00810335020228 | II Programmable 20mLPump |
00810335020242 | II Programmable 40mLPump |
- Lot codes and dates
All Physician Order Form (PL-15400-00Nov. 2018)
- Amount recalled
- N/A
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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