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Recall Observatory FDA recall evidence

Device product

SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009

Z-0107-2019

September 18, 2018

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 81158
Status
Terminated
Classification
Class II
Quantity
354 units
Official record key
device-enforcement:Z-0107-2019

Official wording

Reason: If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit exceeded error, preventing him or her from programming the infusion.

Code information: UDI 00085412610900 All Serial Numbers distributed prior to 07/09/2018

Distribution pattern: NJ

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit exceeded error, preventing him or her from programming the infusion.