Baxter GEM Flow Coupler Monitor Recalled for Firmware Shutdown Issue
Baxter Healthcare is recalling 60 units of the GEM Flow Coupler Monitor because a firmware issue may cause intermittent shutdowns when WiFi is not connected.
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: The recall involves a medical device with a functional defect that could lead to unexpected shutdowns during use. While no specific injuries are reported, the risk of harm from device failure in a surgical context aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling 60 units of the GEM Flow Coupler Monitor (Product Code: 5156-00000-011, All Serial numbers). The recall is due to a firmware issue that may cause the device to intermittently shut down when a WiFi connection is not established.
The affected devices were distributed in the United States to the following locations: VA, GA, MD, PA, DC, WI, LA, MN, FL, IN, MI, AZ, TX, MS, MA, NY, SC, WA, and CA. The product is prescription-only and is used in microsurgery settings.
Healthcare facilities should stop using the affected devices and contact Baxter Healthcare Corporation for further instructions on the recall.
The recalled product
- Product
- Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 60
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)
- Product Code: 5156-00000-011
- All Serial numbers
Distribution
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