SIGMA Spectrum infusion pumps recalled over defective grease on the gears
Baxter Healthcare is recalling 585 SIGMA Spectrum Infusion Pumps because defective grease on the cam and motor gears could lead to over-infusion or a free-flow situation.
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 defect could result in over-infusion or free flow, and no injuries are reported.
Plain-English summary
The SIGMA Spectrum Infusion Pump, model/catalog number 35700BAX2, is being recalled by Baxter Healthcare Corporation.
The record states that certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.
The record lists 585 units under GTIN 00085412498683, with serial numbers recorded in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class II.
Over-infusion or free flow delivers more medication than intended. The enforcement record reports no injuries. Facilities should follow Baxter's instructions.
The recalled product
- Product
- SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion pump
- Affected units
- 585
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)
- GTIN 00085412498683
Distribution
Distributed nationwide across the United States.
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