Baxter SIGMA Spectrum Infusion Pump Recall for Safety Communication Update
Baxter Healthcare is recalling SIGMA Spectrum Infusion Pumps to update the Instructions for Use (IFU) regarding cleaning practices.
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 is updating the device IFU for safety communication regarding cleaning practices."
Plain-English summary
Baxter Healthcare Corporation is recalling the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8). The recall involves 310,969 units distributed throughout the United States, St. Thomas USVI, and Puerto Rico, as well as foreign distribution including Canada and several Caribbean nations.
The recall is initiated to update the device Instructions for Use (IFU) for safety communication regarding cleaning practices. This action addresses documentation and safety communication rather than a reported defect causing injury or illness.
Healthcare providers and consumers should refer to the updated IFU for proper cleaning practices. The recall number is Z-0121-2021.
The recalled product
- Product
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 310,969
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 (3)
- Product Code: 35700BAX
- All Serial Numbers
- GTIN 00085412091570
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 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.
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