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U.S. Department of Health and Human Services

Class 2 Device Recall Flowonix Physician Order Form (PL1540000)

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 Class 2 Device Recall Flowonix Physician Order Form (PL1540000)see related information
Date Initiated by FirmMay 26, 2021
Create DateJuly 01, 2021
Recall Status1 Terminated 3 on February 20, 2024
Recall NumberZ-1996-2021
Recall Event ID 88044
PMA NumberP080012 
Product Classification Pump, infusion, implanted, programmable - Product Code LKK
ProductPhysician 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)
FEI Number 3010079947
Recalling Firm/
Manufacturer		 Flowonix Medical Inc
120 Forbes Blvd Ste 170
Mansfield MA 02048-1150
For Additional Information ContactSAME
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
ActionFlowonix 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
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = LKK
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