Baxter Sigma Spectrum Infusion Pump Recalled for Incomplete Testing Documentation
Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because final release testing was improperly documented, omitting critical safety checks.
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 source text explicitly states that the hazard 'may result in serious adverse health consequences,' which aligns with the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Baxter Healthcare Corporation is recalling 444 units of the Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6). The recall affects serial number 758477 and was distributed nationwide in the United States and Puerto Rico.
The recall was initiated because a service technician improperly documented final release testing on the product. The documentation indicated that the full battery of release tests were performed, but several tests were actually omitted. Specifically, the omitted tests include air-in-line detection at 400ml/hr and 800ml/hr, and verification of upstream occlusion detection at 800ml/hr.
The source text states that improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences. The device is intended for the controlled administration of fluids, including pharmaceutical drugs, blood, and blood products, via intravenous, arterial, subcutaneous, intrathecal, epidural, or irrigation routes.
The recalled product
- Product
- Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical…
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Affected units
- 444
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 (1)
- Serial number 758477
Distribution
Part of a larger recall action
This product is one of 5 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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