Smiths Medical recalls a specific tracheostomy kit model due to incorrect labeling that could lead to improper use in medical settings. Affected units may have been mislabeled as 7.0mm when they are 9.0mm.
One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit.
Smiths Medical is recalling a specific trache:ostomy dilation kit model because it may have been incorrectly labeled as a smaller size than it actually is. This could lead to improper use if the kit is used for a larger airway than intended.
The kit may be labeled as a 7.0mm internal diameter when it is actually a 9.0mm kit. Using the wrong size could cause improper tracheostomy dilation, potentially leading to complications like airway obstruction or injury.
Healthcare professionals using this specific tracheostomy kit in controlled medical settings like ICUs or operating rooms. Patients receiving tracheostomy procedures using the recalled model are at risk if the kit is mislabeled.
Check the lot number on the kit packaging. The affected model has a lot number of 4072715 and is labeled as a 9.0mm kit but may have been incorrectly labeled as 7.0mm.
Verify the lot number and internal diameter size on the kit packaging. The affected lot is 4072715.
The recall is due to potential mislabeling, not inherent danger. If the kit is used correctly with the right size, it should be safe.
Look for the lot number 4072715 on the packaging. The kit may be labeled as a 7.0mm size when it is actually a 9.0mm kit.
Check the lot number and internal diameter size. If it matches the recalled model, contact Smiths Medical for guidance.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1993-2021 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1993-2021 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.
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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.
