Flow Coupler Monitor recall
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Why was Flow Coupler Monitor recalled?
A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code: 5156-00000-011, All Serial numbers
- Product
- Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 60 units
- Distribution
- U.S. distribution only: VA, GA, MD, PA, DC, WI, LA, MN, FL, IN, MI, AZ, TX, MS, MA, NY, SC, WI, WA, MI, CA.
- Recall date
- July 8, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)