RespVent recalls adult tracheostomy suction systems with potential catheter disconnection risk. Affected units may cause suction failure or difficulty removing catheter from patient airway.
It has been determined that some units of catheters were not tightly connected to the thumb port. This may result in the catheter disconnecting from the thumb port which could reduce the suction performance and make it difficult to remove from the patient's trachea.
RespVent recalls certain tracheostomy suction systems that may disconnect from the thumb port, reducing suction performance and making it hard to remove the catheter from the patient's airway. This could lead to incomplete suctioning or difficulty clearing secretions.
The catheter may not connect tightly to the thumb port, causing it to disconnect during use. This could reduce suction effectiveness and make it difficult to remove the catheter from the patient's trachea, potentially leading to incomplete suctioning or blockages.
Healthcare professionals using the RespVent tracheostomy suction system for patients with tracheostomies are most at risk. Patients with tracheostomies who use this system could experience suction failure or difficulty clearing secretions.
Check for the product name 'RespVent Closed Suction System T-Piece Tracheostomy Adult' with specific dimensions (4.6mm diameter, 30.5cm length) and the lot numbers KS1901013 or KS1902002. The product was sold from March 31, 2001 to June 31, 2019.
Ensure the catheter is securely connected to the thumb port before use. If loose, reattach or contact the manufacturer.
The product may have a risk of catheter disconnection, which could reduce suction performance. Use with caution and check connections.
The recall does not specify a remedy, so check connections and contact RespVent if issues occur.
Look for the product name 'RespVent Closed Suction System T-Piece Tracheostomy Adult' with specific dimensions and lot numbers KS1901013 or KS1902002.
We’ve drafted a message you can send RespVent to request your refund or repair — edit it as you like.
Subject: Recall Z-1443-2020 — RespVent RespVent Hello, I own a RespVent that is covered by recall Z-1443-2020 from RespVent. 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.