Baxter SIGMA Spectrum Infusion Pump Recall for Incorrect Software Version
Baxter Healthcare is recalling 28 SIGMA Spectrum Infusion Pump V8 units due to incorrect software versions. Affected facilities should contact Baxter immediately.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification indicates a serious device defect with potential for adverse health consequences. No illnesses, injuries, or deaths are documented in this recall notice.
Plain-English summary
Baxter Healthcare Corporation is recalling 28 units of the SIGMA Spectrum Infusion Pump V8 (Model 35700BAX2). These devices may have an incorrect software version.
The affected units were distributed in California, Florida, Illinois, Kansas, Michigan, Mississippi, New York, Ohio, Oklahoma, and Virginia, and each has been identified by specific serial number.
Individuals and facilities in possession of an affected device should contact Baxter Healthcare Corporation immediately for instructions.
The recalled product
- Product
- Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- software-defect
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)
- UDI-DI: 00085412498683
- Serial Numbers: 2006307
- 2052091
- 2093765
- 2095360
- 2104302
- 2119236
- 2141815
- 2025925
- 2067699
- 2094483
- 2095541
- 2105238
- 2119436
- 2143406
- 2034297
- 2074097
- 2094580
- 2096351
- 2105769
Distribution
Distributed in 10 states:
- CA
- FL
- IL
- KS
- MI
- MS
- NY
- OH
- OK
- VA
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