Baxter Sigma Spectrum Infusion System Recalled for Missing Mounting Screws
Baxter Healthcare is recalling 66 units of Sigma Spectrum Infusion System (V6) due to potential missing motor mounting screws that may have occurred during servicing. Missing screws could affect the device's operation.
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: This is an FDA Class I recall, which requires a minimum severity score of 4 per FDA regulatory guidelines. No illnesses, injuries, or deaths are reported in the source material.
Plain-English summary
Baxter Healthcare Corporation is recalling 66 units of the Sigma Spectrum Infusion System (V6 Platform) distributed nationwide. The affected units are identified by UDI/DI 00085412091570 and specific serial numbers ranging from 704198 to 1024109.
The recall is due to the potential for missing motor mounting screws that may have occurred during the servicing process. Missing mounting screws could affect the device's structural integrity and proper operation.
Healthcare facilities, clinicians, and patients who have received or are using any of these recalled units should verify the serial numbers of their devices. Those with affected units should contact Baxter Healthcare Corporation for instructions on how to proceed.
For more information about this recall, contact Baxter Healthcare Corporation or visit the FDA's medical device database. Report any adverse events related to this device to the FDA.
The recalled product
- Product
- Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion System
- Affected units
- 66
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 00085412091570
- Serial Numbers: 704198
- 728888
- 751492
- 758399
- 758614
- 761662
- 763197
- 766291
- 772611
- 773302
- 775486
- 778837
- 785425
- 793453
- 795240
- 798065
- 814485
- 818850
- 826637
Distribution
Distributed nationwide across the United States.
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
Same manufacturer · Baxter Healthcare Corporation
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