Baxter Spectrum IQ Infusion System may have missing motor mounting screws
Baxter Spectrum IQ Infusion Systems may lack motor mounting screws due to a servicing defect. The FDA Class I recall affects 323 units distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall classification requires a minimum severity score of 4 per the severity rubric, regardless of reported injuries.
Plain-English summary
Baxter Healthcare Corporation is recalling 323 units of the Baxter Spectrum IQ Infusion System with Dose IQ Safety Software nationwide due to an FDA Class I recall.
Motor mounting screws may be missing from affected units, a defect that may have occurred during the servicing process.
The recall affects 323 units of the infusion system distributed throughout the United States. Specific serial numbers and UDI information are available from the FDA for identification of affected devices.
Healthcare facilities and practitioners using affected units should discontinue use and contact Baxter Healthcare Corporation for replacement guidance or further instructions.
The recalled product
- Product
- Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion System
- Hazard
- missing-components
- mechanical-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 00085412610900
- Serial Numbers: 3020290
- 3020992
- 3020996
- 3021929
- 3023080
- 3023183
- 3023537
- 3023758
- 3500529
- 3502799
- 3502864
- 3510806
- 3511639
- 3512647
- 3514801
- 3516888
- 3517399
- 3517517
- 3518558
Distribution
Distributed nationwide across the United States.
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