Teleflex recalls Flexi-Set Uncuffed Endotracheal Tube and Stylet Set (REF 506545) due to reported disconnections. Affected units have specific batch numbers and UDI/DI codes. Stop using if you own this medical device.
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Teleflex is recalling Flexi-Set Uncuffed Endotracheal Tube and Stylet Sets with a specific reference number (REF 506545) because reports indicate the 15mm connector can disconnect from the tube. This could lead to breathing difficulties during medical procedures if the tube becomes disconnected. Patients and medical staff using these devices should check if their unit is affected and take action as instructed.
The hazard involves the 15mm connector potentially disconnecting from the endotracheal tube during use. This disconnection could interrupt the airway, leading to breathing difficulties or complications during medical procedures. The issue is reported but not confirmed to cause injury in all cases.
Medical professionals and patients who use the Flexi-Set Uncuffed Endotracheal Tube and Stylet Set (REF 506545) are likely affected. Those in healthcare settings or undergoing procedures requiring endotracheal tubes are at higher risk.
Check for the product name 'Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal' with reference number REF 506545. Affected units have specific batch numbers and UDI/DI codes listed in the recall notice.
Identify if your device has the reference number REF 506545 and the listed batch numbers or UDI/DI codes.
The recall reports disconnections but does not confirm injuries. The hazard is reported, so users should check if their device is affected.
Check for the reference number REF 506545 and the specific batch numbers or UDI/DI codes listed in the recall notice.
The recall does not specify a remedy, so users should check if their device is affected and contact Teleflex for further instructions.
We’ve drafted a message you can send Teleflex to request your refund or repair — edit it as you like.
Subject: Recall Z-1858-2023 — Teleflex Teleflex Hello, I own a Teleflex that is covered by recall Z-1858-2023 from Teleflex. 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.
