Flexicare recalls ProVu Single Use Video Stylets with specific part numbers due to potential occlusion of endotracheal tubes when cuff is overinflated, risking ventilation difficulties.
When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance to gas flow and difficulty in ventilating the patient.
Flexicare is recalling specific ProVu Single Use Video Stylets with endotracheal tubes because overinflating the cuff can block the tube and make it hard to ventilate patients. This could lead to breathing problems for patients using the device.
Overinflating the video stylet cuff can cause blockage in the corrugated section of the endotracheal tube, increasing resistance to gas flow and making it difficult to ventilate patients properly. This could lead to breathing problems if the tube becomes obstructed.
Healthcare professionals using these stylets for endotracheal tube ventilation in medical settings are most at risk. Patients receiving ventilation support with these devices could experience breathing difficulties.
Check for part numbers 038-990-080U (8.0), 038-990-075U (7.5), or 038-990-070U (7.0) on the stylet. These products were sold with specific lot numbers listed in the recall notice.
Identify the part number on the stylet to confirm if it's in the recalled list (038-990-080U, 038-990-075U, or 038-990-070U).
Reach out to Flexicare Medical Ltd. for specific instructions on how to handle the recalled product.
Part numbers 038-990-080U (8.0), 038-990-075U (7.5), and 038-990-070U (7.0) are recalled.
Check the part number on the stylet; if it's 038-990-080U, 038-990-075U, or 038-990-070U, it's likely recalled.
Contact Flexicare Medical Ltd. for specific instructions on handling the recalled product.
We’ve drafted a message you can send Flexicare to request your refund or repair — edit it as you like.
Subject: Recall Z-0497-2021 — Flexicare Flexicare Hello, I own a Flexicare that is covered by recall Z-0497-2021 from Flexicare. 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.
