Smiths Medical recalls Bivona Aire-Cuf Endotracheal Tubes with 325mm shaft length due to inadequate pouch seal risking compromised sterile barrier. Check SKUs and lots for affected items.
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
Smiths Medical is recalling Bivona Aire-Cuf Endotracheal Tubes with a 325mm shaft length because the pouch seal may not be sterile, potentially causing infections during medical procedures. This is a serious safety issue for healthcare providers using these tubes.
The pouch seal on these tubes may not maintain sterility properly, which could lead to infections during medical procedures. This is specific to tubes with a 325mm shaft length, as the seal design is inadequate for that size.
Healthcare providers who use these endotracheal tubes for medical procedures are most at risk. Patients receiving care with these tubes could face infection if the sterile barrier is compromised.
Check the product's SKU and lot numbers listed in the recall notice. Affected tubes have a 325mm shaft length and include specific SKUs like 25W080, 25W085, 25W090, 25W095, 35W080, 35W085, 35W090, and 35W095.
Identify your tube's SKU and lot number to confirm if it's affected by this recall.
The pouch seal may not maintain sterility properly, which could lead to infections during medical procedures for tubes with a 325mm shaft length.
Tubes with a 325mm shaft length and specific SKUs including 25W080, 25W085, 25W090, 25W095, 35W080, 35W085, 35W090, and 35W095.
No, but healthcare providers should check if their tubes are affected and take action if they are.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0177-2022 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0177-2022 from Smiths 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
