Smiths Medical recalls specific FlexTend Tracheostomy Tubes due to potential incorrect packaging with a V-neck flange instead of straight flange. Affected units may need verification.
A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.
Smiths Medical is recalling a specific model of neonatal/pediatric tracheostomy tubes because some were incorrectly packaged with a V-neck flange instead of a straight fl. This could cause issues during medical procedures if the wrong flange is used.
The tube may have been packaged with a V-neck flange instead of a straight flange. This could lead to improper fitting during medical procedures, potentially causing complications for patients.
Healthcare providers using the specific model and lot number of the FlexTend Tracheostomy Tube are affected. Patients using these tubes could be at risk if the incorrect flange is present.
Check for the model number REF 60PFSS45 and lot number 3991195 on the tube packaging. The affected units were sold by Smiths Medical.
Look for the model number REF 60PFSS45 and lot number 3991195 on the tube packaging.
The specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.
Check the tube packaging for the model number REF 60PFSS45 and lot number 3991195. If you have the affected model and lot, contact Smiths Medical for guidance.
The recall is for potential incorrect packaging, but the record does not specify a risk of serious injury.
We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0726-2021 — Smiths Medical Smiths Medical Hello, I own a Smiths Medical that is covered by recall Z-0726-2021 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.
