Baxter Spectrum IQ Infusion Pump Recalled for Potential Front Panel Cracks
Baxter Healthcare Corporation has recalled 9 Spectrum IQ Infusion Pumps due to potential cracks on the front panel mount. Units distributed in Ohio and Wisconsin are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a potential structural defect in an infusion pump used to deliver medications to patients. No illnesses or injuries have been reported. The recall addresses a risk-of-harm product where the hazard is theoretical rather than confirmed.
Plain-English summary
Baxter Healthcare Corporation has recalled the Spectrum IQ Infusion Pump, Product Code 357009, due to a potential for cracks on the front panel mount.
The recall affects nine units distributed in the United States, specifically in Ohio and Wisconsin. The affected devices carry serial numbers 3770692, 3770755, 3770781, 3770816, 3770932, 3771122, 3771364, 3771374, and 3771419 (UDI/DI 00085412610900).
The FDA classified this recall as Class II.
The recalled product
- Product
- Spectrum IQ Infusion pump, Product Code 357009
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Affected units
- 9
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 (10)
- UDI/DI 00085412610900
- Serial Numbers: 3770692
- 3770755
- 3770781
- 3770816
- 3770932
- 3771122
- 3771364
- 3771374
- 3771419
Distribution
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