Baxter Recalls Sigma Spectrum Volumetric Infusion Pumps Due to System Errors
Baxter Healthcare is recalling Sigma Spectrum Volumetric Infusion Pumps due to repeated System Error 322 occurrences.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library due to repeated System Error 322 occurrences."
Plain-English summary
Baxter Healthcare Corporation has issued an Urgent Device Correction for the SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library. The recall is due to repeated System Error 322 occurrences.
The affected products are intended for the controlled administration of intravenous fluids, including pharmaceutical drugs, blood, blood products, and mixtures of required patient therapy. The recall covers 277,096 units.
Distribution was worldwide, including the USA nationwide (including Puerto Rico) and Canada. Product codes are 35700BAX and 35700ABB. The source text does not specify specific actions for consumers or healthcare providers beyond the issuance of the correction.
The recalled product
- Product
- SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs…
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 277,096
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 (2)
- Product Codes: 35700BAX
- 35700ABB
Distribution
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