Z-1996-2021Class II

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

Name: Z-1996-2021 Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra...
Creator: Flowonix Medical Inc
Published: 2021-05-26
License: https://open.fda.gov/license/

Flowonix Medical Inc / initiated 2021-05-26 / Terminated / root cause: labeling and UDI

FDA source

Flowonix Medical Inc began a recall of Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable Infusion Pump System: MODEL/CATALOG #(s)... on 2021-05-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1996-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-26
Posted: 2021-07-01
Terminated: 2024-02-20
Recalling firm: Flowonix Medical Inc
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
Product code: LKK Pump, Infusion, Implanted, Programmable
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
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Flowonix Customer letters) have been mailed via USPS 2 day priority mail with electronic tracking on 5/26-5/27. Letter states reason for recall, health risk and Actions to be taken by the Customer: 1) Discontinue the use and distribution of the Physician Order Form (PL-15400-00, Nov. 2018). This form is no longer available for use and shall no longer be used. 2) Complete and return the attached response form to Flowonix. Should you have any questions, please contact your Flowonix Representative or our Technical Solutions Department at (855) 356-9665
Distribution: US Nationwide distribution.
Product codes and lots: All Physician Order Form (PL-15400-00, Nov. 2018)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1996-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1996-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-07	2021-07-01

Product code LKK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)