Baxter Infusion Pumps Recalled for Battery Performance Issues
Baxter Healthcare is recalling 589,704 infusion pumps due to battery performance issues related to prolonged storage.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a performance issue (battery) without reporting specific injuries, deaths, or hospitalizations, fitting the criteria for a moderate severity recall involving a potential risk of harm.
Plain-English summary
Baxter Healthcare Corporation is recalling 589,704 units of Infusion Pumps. The recall is due to battery performance issues related to prolonged storage.
The affected products include Infusion Pumps with product codes 35700ABB, 35700BAX, 35700BAX2, and 3570009, as well as specific battery codes. The devices were distributed domestically across all 50 states, the District of Columbia, and Puerto Rico, as well as internationally to Canada, Barbados, Bermuda, St. Thomas, Guyana, Trinidad and Tobago, Jamaica, and Nassau Bahamas.
Consumers and healthcare facilities should contact Baxter Healthcare Corporation for instructions on how to proceed with the recall.
The recalled product
- Product
- Infusion Pump
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 589,704
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 (7)
- Infusion Pump Product codes: 35700ABB
- 35700BAX
- and 35700BAX2 Battery codes: 35083
- 35162
- 35195
- and 35724. Infusion Pump Product codes: 35700ABB
- 35700BAX2 3570009 Battery codes: 35223 and 36010
Distribution
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