Baxter SIGMA Spectrum Infusion Pump recall due to inadequate pre-release testing
Baxter Healthcare is recalling the SIGMA Spectrum Infusion Pump (Serial 2158913) distributed nationwide in Florida. The recall is due to improperly performed testing procedures prior to release, which may affect device function.
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: This is a FDA Class II recall for a critical-care medical device. Although no hospitalizations, injuries, or deaths are reported, the manufacturing defect (improperly performed testing) constitutes a risk-of-harm because the pump may not function properly when administering medications.
Plain-English summary
Baxter Healthcare Corporation is recalling the SIGMA Spectrum Infusion Pump, Product Code 35700BAX2, Serial Number 2158913, distributed nationwide in Florida. The recall was initiated because the pump underwent improperly performed testing prior to its release for distribution.
Infusion pumps deliver medications and fluids directly to patients. If testing procedures are inadequate, the pump may not function as intended, potentially affecting patient safety during medication administration.
Customers who have received this pump should contact Baxter Healthcare Corporation immediately for return or replacement instructions. Healthcare facilities should verify the serial number and discontinue use of any affected units.
The recalled product
- Product
- Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Affected units
- 1
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 (1)
- Product Code: 35700BAX2. Serial Number: 2158913.
Distribution
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