Smiths Medical recalls Bivona Uncuffed Wire Endotracheal Tubes with 325mm shaft length due to inadequate pouch seal risking compromised sterile barrier. Affected units include specific SKUs and lots numbers listed in the recall notice.
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
Smiths Medical is recalling Bivona Uncuffed Wire Endotracheal Tubes with a 325mm shaft length because the pouch seal may be inadequate, potentially compromising the sterile barrier. This could lead to infection or other complications during medical procedures.
The pouch seal on these tubes may not be adequate, which could compromise the sterile barrier. This means the tubes might not stay sterile during medical procedures, increasing the risk of infection or contamination.
Healthcare professionals using these tubes for intubation procedures are most at risk. Patients undergoing surgery or medical treatments requiring endotracheal tubes may be affected if they use the recalled products.
Check for the product name 'Bivona Uncuffed Wire Endotracheal Tubes' with a shaft length of 325mm. Affected units include specific SKUs (15W080, 15W085, 15W090, 15W095) and the listed lot numbers.
Identify the SKU and lot numbers listed in the recall notice to confirm if your tubes are affected.
The recall is due to an inadequate pouch seal that may compromise the sterile barrier on Bivona Uncuffed Wire Endotracheal Tubes with a 325mm shaft length.
The recall notice does not specify a remedy, so contact Smiths Medical directly for guidance on next steps.
Affected models include SKUs 15W080, 15W085, 15W090, and 15W095 with specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0178-2022 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0178-2022 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.
