Smiths Medical ASD Inc. 2024-09-04 Health critical FDA
Health · FDA · Recall #FDA-Z-2614-2024
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List… Recall
Issued September 4, 2024 · Smiths Medical ASD Inc.
In September 2024, Smiths Medical ASD Inc. recalled the a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
What you should do
- 1 Stop using a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Smiths Medical ASD Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Smiths Medical ASD Inc.
- Category
- Health
- Recall date
- September 4, 2024
- Units affected
- Not reported
- Sold at
- Worldwide distribution.
- Recall number
- FDA-Z-2614-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Smiths Medical ASD Inc. has 4 recalls in our database, including 4 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.