Reported Jul 8, 2020 · Ongoing
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
- Lot codes and dates
- Product Code5156-00000-011, All Serial numbers
- Amount recalled
- 60 units
Where it was sold
Why it was recalled
A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.
This product could cause temporary or reversible health problems — stop using it.
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