FDAClass IIJuly 7, 2021

Physician Order Form recall

Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable Infusion Pump System…

Why was Physician Order Form 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Physician Order Form (PL-15400-00, Nov. 2018)

Product
Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable Infusion Pump System…
Recalling firm
Flowonix Medical Inc
Quantity
N/A
Distribution
US Nationwide distribution.
Recall date
July 7, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
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