Baxter SIGMA Spectrum Infusion Pump Recall for Pumping Mechanism Wear
Baxter is recalling SIGMA Spectrum Infusion Pumps because excessive wear in the pumping mechanism may cause over- or under-infusion of fluids.
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: The recall is classified as FDA Class II. The hazard involves a risk of harm (over- or under-infusion) where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Baxter Healthcare Corporation is recalling the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), model numbers 35700BAX and 35700ABB. The recall involves 173,375 units that were distributed worldwide, including the United States, the District of Columbia, Puerto Rico, and Canada.
The recall is being issued because certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication. This defect could affect the occlusion of the tubing and result in over- or under-infusion of fluids.
Healthcare facilities and users should check their inventory for the affected model numbers and GTIN 00085412091570. Baxter has not reported any illnesses or injuries associated with this defect.
The recalled product
- Product
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Affected units
- 173,375
Distribution
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