Infusion pumps recalled after being released without full testing
Baxter Healthcare is recalling 5 Spectrum IQ Infusion Pumps because they were released without full testing being performed, including occlusion alarm testing.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states the pumps were released without occlusion alarm testing, so a safety alarm is unverified, and no injuries are reported.
Plain-English summary
The Spectrum IQ Infusion Pump, model/catalog number 3570009, one unit per carton, is being recalled by Baxter Healthcare Corporation.
The reason given in the enforcement record is that pumps were released without full testing being performed, including occlusion alarm testing.
The record lists 5 units under GTIN 00085412610900, serial numbers 3815663, 3823468, 3824743, 3825234 and 3825599. Distribution was to Ohio in the United States. The FDA has classified the action as Class II.
An occlusion alarm that has not been tested cannot be relied on to warn of a blocked line. The enforcement record reports no injuries. Facilities should quarantine the affected serial numbers and follow Baxter's instructions.
The recalled product
- Product
- Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion pump
- Affected units
- 5
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 (6)
- Lot Code: GTIN 00085412610900
- Serial Numbers 3815663
- 3823468
- 3824743
- 3825234
- and 3825599
Distribution
Distributed in 1 state:
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