LifeShield Infusion Safety Software Suite 17003-02Recalls & reported problems
ICU Medical, Inc. · GTIN for 17003-02, 1/EA · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Nov 24, 2025Class IIOpen, Classified
Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.
Z-0966-2026 · Root cause: Software Design Change · Recall details · FDA record ↗
- Nov 24, 2025Class IIOpen, Classified
For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.
Z-0965-2026 · Root cause: Software Design Change · Recall details · FDA record ↗
Other Infusion safety management software devices
- SIGMA Spectrum Infusion Pump 35700BAX2Baxter Healthcare Corporation · Infusion safety management software9 recalls12 deaths11,585 reports
- Spectrum IQ 3570009Baxter Healthcare Corporation · Infusion safety management software11 recalls10 deaths9,086 reports
- Alaris 8975Carefusion 303, Inc. · Infusion safety management software169 reports
- Alaris 9601Carefusion 303, Inc. · Infusion safety management software2 recalls0 reports
- BD Alaris™ Infusion Adapter, Software Not ApplicableCarefusion 303, Inc. · Infusion safety management software1 recall0 reports
- LifeShield Infusion Safety Software Suite - LifeShield DLM 2.1Icu Medical, Inc. · Infusion safety management software1 recall0 reports
- BD Intelliport 516704Becton, Dickinson And Company · Infusion safety management software28 reports
- Ivenix Infusion System 030-0027-06Fresenius Kabi AG · Infusion Safety Management Software3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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