The Tri-Flo Subglottic Suction System
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part number: CM28010; Lot/Serial Numbers: 0001158835 , 0001158836, 0001158837, 0001185564, 0001194114 , 0004008255, 0004008256.
- 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:
- Vyaire Medical
- Reason for Recall:
- Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Subglottic Suction System. The distal soft tip of the catheter has been identified as having the potential to break off during patient use and result in aspiration of a solid foreign body.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
The Tri-Flo Subglottic Suction System
Product Codes/Lot Numbers:
Part number: CM28010; Lot/Serial Numbers: 0001158835 , 0001158836, 0001158837, 0001185564, 0001194114 , 0004008255, 0004008256.
Distribution:
Distributed in: AZ, CA, CT, FL, GA, IA, IL, IN, MA, MD, MN, NJ, OH, OK, SD, TX, WA, WI
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2826-2018
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