Smiths Medical recalls specific model 60PFS45 tracheostomy tubes with incorrect straight neck flange that may cause tissue injury if used improperly.
Smiths Medical became aware that three lot numbers of a specific model of Bivona¿ Cuffless FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) may have been incorrectly packaged with a straight neck flange instead of a V-neck flange. As a result, there is potential for patient injury if an incorrect device or accessory is selected for use. This use could lead to an internal injury resulting from excessive device contact with tissue, or an external patient injury due to external portions of the device pressing into or rubbing against tissue.
Smiths Medical is recalling certain tracheostomy tubes that may have been incorrectly packaged with a straight neck flange instead of a V-neck flange. This could cause tissue injury if the wrong tube is used during medical procedures.
The tubes may have been incorrectly packaged with a straight neck flange instead of the required V-neck flange. Using the wrong tube could cause internal tissue injury from excessive contact or external injury from the tube pressing against tissue.
Healthcare providers using the specific model 60PFS45 tracheostomy tubes with lot numbers 3991171, 3991172, and 3988103 are most at risk. Patients receiving these tubes could experience tissue injury if the incorrect device is selected.
Check for the model number 60PFS45 and lot numbers 3991171, 3991172, or 3988103 on the tube packaging. These specific lots were recalled due to potential packaging errors.
Look for the model number 60PFS45 and lot numbers 3991171, 3991172, or 3988103 on the tube packaging.
The recalled model is 60PFS45.
Lot numbers 3991171, 3991172, and 3988103 are affected.
Using the recalled tubes could cause tissue injury due to incorrect flange design.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1145-2021 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-1145-2021 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.
