Baxter SIGMA Spectrum Infusion Pump Recall for Safety Communication Update
Baxter Healthcare is recalling 152,539 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 source text explicitly identifies this as a Class I recall. Per the rubric, if the agency's own classification is FDA Class I, the score must be at least 4 (Severe).
Plain-English summary
Baxter Healthcare Corporation is recalling 152,539 units of the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8). The recall is initiated to update the device Instructions for Use (IFU) to improve safety communication regarding cleaning practices.
The affected devices were distributed throughout the United States, St. Thomas USVI, and Puerto Rico. Foreign distribution included Canada and several Caribbean nations, including Barbados, Trinidad and Tobago, Jamaica, Bahamas, Bermuda, and Guyana. The product code is 35700BAX2, and the recall applies to all serial numbers.
This is a Class I recall. Users should refer to the updated Instructions for Use for the revised cleaning practices.
The recalled product
- Product
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Affected units
- 152,539
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: 35700BAX2
- All Serial Numbers
- GTIN 00085412498683
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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