Baxter SIGMA Spectrum V6 infusion pumps may carry incorrect software version
Baxter SIGMA Spectrum Infusion Pump V6 units are being recalled because certain pumps may have an incorrect version of software. 14 units are affected.
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: FDA Class I recall, which the rubric floors at Severe; no injury is reported in the source, so it does not escalate to Critical.
Plain-English summary
The Baxter SIGMA Spectrum Infusion Pump V6, model number 35700BAX, UDI-DI 00085412091570, is being recalled. The action covers 14 units, identified by the serial numbers in the recall notice.
The stated reason is that certain Spectrum infusion pumps may have an incorrect version of software. The FDA classified the action as Class I, its most serious classification.
Distribution was in California, Florida, Illinois, Kansas, Michigan, Mississippi, New York, Ohio, Oklahoma and Virginia. The pumps are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected pumps using the model number, UDI-DI and serial numbers above and follow the instructions issued by Baxter.
The recalled product
- Product
- Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion pump
- Affected units
- 14
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 (13)
- UDI-DI: 00085412091570
- Serial Numbers: 765100
- 772744
- 789742
- 841197
- 867753
- 920606
- 1024015 770164 788724
- 793079
- 842498
- 918342
- 962810
- 1027523
Distribution
Part of a larger recall action
This product is one of 2 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.
See all 2 products in this recall →Related recalls
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Same hazard · incorrect software version
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