Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Software v.2.00.29 Serial numbers: D18L0003 D18L0022 D18L0013 D18L0035 D18L0004 D18L0025 D18L0014 D18L0036 D18L0006 D18L0026 D18L0015 D18L0037 D18L0010 D18L0027 D18L0016 D18L0038 D18L0009 D18L0028 D18L0017 D18L0034 D18L0008 D18L0029 D18L0018 D18L0039 D18L0007 D18L0030 D18L0019 D18L0040 D18L0011 D18L0031 D18L0021 D18L0041 D18L0005 D18L0032 D18L0023 D18L0042 D18L0012 D18L0033 D18L0024 D18L0020
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Flowonix Medical Inc
- Reason for Recall:
- The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
Product Codes/Lot Numbers:
Software v.2.00.29 Serial numbers: D18L0003 D18L0022 D18L0013 D18L0035 D18L0004 D18L0025 D18L0014 D18L0036 D18L0006 D18L0026 D18L0015 D18L0037 D18L0010 D18L0027 D18L0016 D18L0038 D18L0009 D18L0028 D18L0017 D18L0034 D18L0008 D18L0029 D18L0018 D18L0039 D18L0007 D18L0030 D18L0019 D18L0040 D18L0011 D18L0031 D18L0021 D18L0041 D18L0005 D18L0032 D18L0023 D18L0042 D18L0012 D18L0033 D18L0024 D18L0020
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1713-2019
Related Recalls
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
Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
Flowonix Medical
A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.
A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.