Reported Sep 4, 2024 · Ongoing
PORTEX Bivona Tracheostomy Silicone Tube, labeled as
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 as
6 of 6 products
| Model / number | Product as published |
|---|---|
3.0MM | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) |
3.5MM | FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) |
4.0MM | FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) |
4.5MM | FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) |
5.0MM | FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) |
5.5MM | FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) |
- Lot codes and dates
a) UDI/DI 15021312516760Product Code/List Number/Item Code 60PFSS30
- Lot Numbers
105 of 105 codes
386821538682163868217386821838743113880720388775538948943904669390797139179823926967393347639396353942492394627839462793946280396258039826863988113399118340012044011379401138040155594029512403372840337294040575404800940537134060206407085340770714077072408390840914124096836410525641104584113107411911841280374130977413402141424214145693415104741566124159997416385141715544176212417621341804974185426419628142013854204821
- Lot Numbers
285 of 285 codes
384007338400743845208385346738534683853469385817138611483863922386420838683243868325387103438710353874315387431638743173874318387431938743203877667388069838806993894862389486338948643897856389785738978583901284390128539036983907977390797839079793917978391797939209683923714392697839269793930039393113939396263939627393962839424523942453394245439462323946233394623439462353946236394623739462383946239394624039503933955795
- Lot Numbers
267 of 267 codes
385347238682343868235386823638682373868238386823938682413868242386824338682443871051388070438842533887750388775138915143891515389487038948713894872389487338978703897871390129939013003903699391798339209443920945392695939396383942475394247639424773942478394247939424803942481394624739462483946249394625039462513946252395929539592963959297395929839826913982692398269339881213988122398812339881243988125398812639881273991189
- Lot Numbers
133 of 133 codes
385347338534743868198386819938743053880707388426138949053897859390467439080033918013392696039300263930027393962439396693942482394629139462923955775395577639625733982694398269539881283988129399119539911963991197399119839911994001213400121440082254008226401557040155714023790403373640357554040577404802640516444051645405624240602184060219406319140662934071974408391140913934093740409783641052544107585411046241160914122447
- Lot Numbers
76 of 76 codes
384005738682203868221386822238807143884270389490738978683904679391143639180233920950393002939300303946241394624239462433949030398269639912003991201400822740113834015572402379140266964033737403575640439344051656405371040719754083923408601140978374110463412245441280234139014414569841566194161975416815241762344185430419629042013914206832421278642187144223737423151642542664267859427647742793444289495432268443279054335048
- Lot Numbers
38682303871032388067838877323894906390465339114213920954392372939300093930010393001139462773982697399782040082284015573402142440266804035757405165740631924077087408599540914114107589411608941258024128013413401541424354142436415102641566614161961417155841804664196291420139242127874231517426786042793454292178432268543278914327907433505043450374351248435279643744654383652438819943882004389920439920743992094400689
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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