Baxter SIGMA Spectrum Infusion Pump IFU Update for Cleaning Practices
Baxter is updating the Instructions for Use for the SIGMA Spectrum Infusion Pump to clarify safety communication 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 updating the Instructions for Use (IFU) for the Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6). The update is intended to improve safety communication regarding cleaning practices for the device.
The affected product is identified by Product Code 35700ABB and includes all serial numbers. The GTIN for the product is 00085412091570. A total of 9,352 units are involved in this recall.
Distribution of the affected units occurred throughout the United States, St. Thomas USVI, and Puerto Rico. Foreign distribution included Canada and several Caribbean nations, specifically Barbados, Trinidad and Tobago, Jamaica, Bahamas, Bermuda, and Guyana. Users should refer to the updated IFU for the correct cleaning procedures.
The recalled product
- Product
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 9,352
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: 35700ABB
- 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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