GEM FLOW COUPLER Monitor LCD Display Fails to Show Correct Active Channel
Baxter Healthcare is recalling the GEM FLOW COUPLER Monitor due to an LCD display error that may fail to indicate the correct active channel when powered on using battery power. This could lead to incorrect channel selection during use.
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: FDA Class II recall involving a display malfunction in a medical device that could lead to incorrect treatment decisions. No injuries have been reported in the source material, making this a risk-of-harm situation without documented harm.
Plain-English summary
Baxter Healthcare Corporation is recalling the GEM FLOW COUPLER Monitor, model PN 5156-00000-011. The recall affects 122 units with all serial numbers and applies to devices distributed in the United States.
The LCD monitor display may not accurately indicate the correct active channel. The issue occurs when the monitor is turned on using battery power after the device was powered down with channel B selected as the active channel. Upon restart, the display may fail to show the correct active channel.
Healthcare facilities and clinicians using the affected monitors may unknowingly select the wrong channel for treatment or monitoring. This display error could lead to incorrect clinical decisions or treatment delivery.
The recalled product
- Product
- GEM FLOW COUPLER Monitor, PN 5156-00000-011
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 122
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 (2)
- GTIN 00844735006148
- all serial numbers
Distribution
Distribution scope not specified by the agency.
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