Reported Sep 4, 2024 · Ongoing
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product…
Smiths Medical ASD Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
- PORTEX Bivona Tracheostomy Silicone Tube
- labeled asa) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
- Lot codes and dates
- a) UDI/DI 15021312006056. Product Code/List Number/Item Code 670170
- Lot Numbers
680 of 680 codes
377440037744013774402377440637744113774412377441337785273778528377852937785303778531377853237785333778534377853537824883782489378249037824913782492379008137900823790083379008437900853790086379008737900883790089379009037900913790092379009337900943790095379009637900973790098379009937901003797100379710137971023797103379710437971053797106379710737971083797109379711237971133797114379711537971163800538380053938005403800541
- Lot Numbers
480 of 480 codes
378249437824953782496378249737824983782500379000937900103790011379001237900133790014379001537900163790017379416337941643794176379711037971113797122379712338005553800556380055738005583800559380140338014043801405380140638014073801408380140938014103801411380141238014133801414380141538014163801417380141838014193801420380142138014223801423380142438014253801426380142738014283801429382812838281293828130382813138281323828133
- Amount recalled
- 177340 units
This recall covers 28 products
The agency filed one notice per product. You are reading one of them; the other 27 are below.
15 more are in the archive.
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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