Vyaire Medical recalls Tri-Flo Subglottic Suction Systems with potential catheter break-off causing aspiration of foreign bodies. Affected units have specific part and serial numbers.
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.
Vyaire Medical is recalling its Tri-Flo Subglottic Suction System due to a risk that the catheter tip could break off during use, potentially causing a foreign body to be inhaled by patients. This could lead to serious health complications if the broken piece enters the airway.
The catheter's distal soft tip may break off during patient use, which could then be inhaled into the airway. This could cause serious complications like respiratory distress or infection if the broken piece enters the lungs.
Healthcare providers using the Tri-Flo Subglottic Suction System for patient care are most at risk. Patients receiving this equipment during medical procedures could be affected if the catheter breaks off.
Check for the part number CM28010 and serial numbers 0001158835, 0001158836, 0001158837, 0001185564, 0001194114, or 0004008255, 0004008256 on the device or packaging.
Verify the part number CM28010 and serial numbers listed in the recall notice.
The Tri-Flo Subglottic Suction System has a potential risk that the catheter tip could break off during use, which might lead to aspiration of a foreign body in the patient's airway.
The recall notice does not specify a remedy, so check the product details against the listed serial numbers and contact Vyaire Medical for further instructions.
Yes, the broken catheter tip could cause serious complications like respiratory distress or infection if it enters the airway.
We’ve drafted a message you can send Vyaire Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2826-2018 — Vyaire Medical Vyaire Medical Hello, I own a Vyaire Medical that is covered by recall Z-2826-2018 from Vyaire Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
