Recall Z-1996-2021 ยท LKK Pump, Infusion, Implanted, Programmable
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 40mLP
| Date | May 26, 2021 |
| Status | Terminated |
| 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 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.