The Tri-Flo Subglottic Suction System recall: Foreign Material
The Tri-Flo Subglottic Suction System
Why was The Tri-Flo Subglottic Suction System recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Part number: CM28010; Lot/Serial Numbers: 0001158835 , 0001158836, 0001158837, 0001185564, 0001194114 , 0004008255, 0004008256.
- Product
- The Tri-Flo Subglottic Suction System
- Recalling firm
- Vyaire Medical
- Quantity
- 2150 Units Total
- Distribution
- Domestic Distribution: AZ, CA, CT, FL, GA, IA, IL, IN, MA, MD, MN, NJ, OH, OK, SD, TX, WA, WI.
- Recall date
- August 29, 2018
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)