13 results
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49ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling of the device plus the following Prometra II pump labeling is also being revised: Intrathecal Catheter IFU, REF 11823, PL-22790-02; Catheter Revision Kit IFU, REF 11 830, PL-21798-02; Refill Kit IFU, REF 11825, PL-21794-00; Prometra II Patient Implant Card (Permanent) PL-32300-01; Prometra II Patient Implant Card (Temporary): PL-32375-01; Prometra II Patient Guide: PL-31912-01. The Prometra Programmable Infusion Pump System is indicated for intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (sodium chloride injection, USP).
FDA Recall
Terminated
·Flowonix Medical, Inc.·Product code LKK·May 22, 2017
US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082
FDA Recall
Open, Classified
·Flowonix Medical Inc·Product code LKK·December 24, 2019
Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific)
FDA Recall
Open, Classified
·Flowonix Medical Inc·Product code LKK·December 24, 2019
Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
FDA Recall
Terminated
·Flowonix Medical Inc·Product code LKK·March 21, 2019
Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
FDA Recall
Open, Classified
·Flowonix Medical Inc·Product code LKK·December 24, 2019
Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.
FDA Recall
Terminated
·Flowonix Medical Inc·Product code LKK·March 21, 2019
Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion.
FDA Recall
Terminated
·Flowonix Medical Inc·Product code LKK·March 21, 2019
Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)
FDA Recall
Open, Classified
·Flowonix Medical Inc·Product code LKK·December 24, 2019
Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
FDA Recall
Terminated
·Flowonix Medical Inc·Product code LKK·March 21, 2019
Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
FDA Recall
Terminated
·Flowonix Medical Inc·Product code LKK·March 21, 2019
Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082
FDA Recall
Open, Classified
·Flowonix Medical Inc·Product code LKK·December 24, 2019
Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
FDA Recall
Open, Classified
·Flowonix Medical Inc·Product code LKK·December 24, 2019
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
FDA Recall
Terminated
·Flowonix Medical Inc·Product code LKK·May 26, 2021