Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Code: 5156-00000-011, All Serial numbers
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Baxter Healthcare Corporation
- Reason for Recall:
- A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Product Codes/Lot Numbers:
Product Code: 5156-00000-011, All Serial numbers
Distribution:
Distributed in: VA, GA, MD, PA, DC, WI, LA, MN, FL, IN, MI, AZ, TX, MS, MA, NY, SC, WA, CA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2474-2020
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