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Recall Observatory FDA recall evidence

Derived label

Device software or design

Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
firmware code may result in the pump not sending the expected error
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Flowonix Medical Inc

Field note

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