FDA Medical Device Recalls (openFDA)
Flowonix Medical Inc: 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
- Recall number
- Z-1996-2021
- 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
- Status
- Terminated
- Initiated
- 2021-05-26
- Posted
- not on file
- Terminated
- 2024-02-20
- Reason
- 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
- 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
- Quantity
- not on file
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- All Physician Order Form (PL-15400-00, Nov. 2018)
- 510(k) numbers
- not on file
- PMA numbers
- ["P080012"]
- Product code
- LKK
- Firm FEI
- 3010079947
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28