Baxter Sigma Spectrum Infusion Pump Recall for Bearing Failure Risk
Baxter Healthcare is recalling 63,225 Sigma Spectrum Infusion Pumps because bearing lubricant loss can cause flow failures and potential over-infusion.
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: "Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow, which could result in over-infusion. Sigma's evaluation of subsequent…"
Plain-English summary
Baxter Healthcare Corporation is recalling 63,225 Sigma Spectrum Volumetric Infusion Pumps (Part Number 35700) due to a risk of bearing failure. The pumps are intended for the controlled administration of intravenous fluids, including blood, blood products, or pharmaceutical drugs.
The recall is an expansion of a previous action. Sigma's evaluation of complaints indicated that the loss or degradation of bearing lubricant is a significant contributor to bearing failure. This failure can cause inaccurate flow conditions, ranging from back flow to free flow, which could result in over-infusion. The recall includes units manufactured between January 18, 2005, and November 1, 2010, with serial numbers ranging from 700000 through 794213.
The affected units were distributed worldwide, including the United States (nationwide including Puerto Rico), Canada, and Okinawa. Healthcare facilities should check their inventory for these serial numbers and contact Baxter Healthcare for instructions on how to proceed with the recall.
The recalled product
- Product
- Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103 Product Usage: The Spectrum Infusion Pump is intended to be used for the…
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
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)
- Serial numbers ranging from 700000 through 794213: 700000
- 700001
- 700002
- 700003
- 700004
- 700005
- 700006
- 700007
- 700010
- 700012
- 700013
- 700014
- 700017
- 700018
- 700020
- 700021
- 700022
- 700023
- 700024
- 700029
Distribution
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