Reported Aug 29, 2018 · Terminated
The Tri-Flo Subglottic Suction System
Vyaire Medical
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: Vyaire Medical · 26125 N Riverwoods Blvd · Mettawa, IL · 60045-3420
Is this the product you have?
- The Tri-Flo Subglottic Suction System
- Lot codes and dates
- Part numberCM28010
- Lot/Serial Numbers
0001158835000115883600011588370001185564000119411400040082550004008256
- Amount recalled
- 2150 Units Total
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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