Date Initiated by Firm |
May 26, 2021 |
Create Date |
July 01, 2021 |
Recall Status1 |
Terminated 3 on February 20, 2024 |
Recall Number |
Z-1996-2021 |
Recall Event ID |
88044 |
PMA Number |
P080012 |
Product Classification |
Pump, infusion, implanted, programmable - Product Code LKK
|
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
|
Code Information |
All Physician Order Form (PL-15400-00, Nov. 2018) |
Recalling Firm/ Manufacturer |
Flowonix Medical Inc 120 Forbes Blvd Ste 170 Mansfield MA 02048-1150
|
For Additional Information Contact |
SAME 973-426-9226
|
Manufacturer 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
|
FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
PMA Database |
PMAs with Product Code = LKK and Original Applicant = Algorithm Sciences, Inc.
|