Reported Sep 4, 2024 · Ongoing
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b)…
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?
7 of 7 products
| # | Product as published |
|---|---|
| 1 | PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25 |
| 2 | PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30 |
| 3 | PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35 |
| 4 | PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40 |
| 5 | PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45 |
| 6 | PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50 |
| 7 | PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55 |
- Lot codes and dates
a) UDI/DI 10351688518668Product Code/List Number/Item Code 67PFSS25
- Lot Numbers
3897874391141639237434005596401605340160574080314408703842174354327880433493243744124381000b) UDI/DI 10351688518675Product Code/List Number/Item Code 67PFSS30
- Lot Numbers
75 of 75 codes
385340938534103868326387105338776503887740389784539237233931154393966739396683946281395929439617573961758398199739819983987959399113340055974011365403571040516374051638406317340719844075246408929540959164096830411043841160854136131413899041566564159994417158041715814185411419580242127644217436423395242542224273418427645342764544279325429215943226604322661432791043298394334936434435343449804344981434842243572494357250
- Lot Numbers
237 of 237 codes
383579238357933853413385341438581703868261386826238682633868264386826538682663871041387104238743233880694388424538842463887727389151838915193894917389787639012973904685391141839114193917989392096439237413923742393004539300463933473393964139396423939643393964439396453942544394254539425463946257394625839462593946260394626139462623955809395581039593123959313395931439625943965924396592539819993982000398796239879653987984
- Lot Numbers
236 of 236 codes
384006638534163853417385341838534193853420385342138682493868250386825138682523874298387429938776643880692388423638877243891537389153838948753894876390128139012823904661391142639114273923728393001939300203933474393658539396853939686393968739396883942513394251439425153946293394629439462953946296394629739462983955756395575739557583962582396258339625843965918398200439820053982007398584039858413987966398797139911354005610
- Lot Numbers
131 of 131 codes
385342538682773868278386827938682803868281387766338806823880683388771438948793901283390466239079803918011393001839365803939682393968339396843942525394252639425273955763396591239659133965914396591539820513982052398796739880693991136400561640056174011371401448540144864029501403371540357204040574404394140480344053700405624840631764066290407084940770764080797408391940860204091398409264440968434097817410760541104414116098
- Lot Numbers
88 of 88 codes
384007738682703868271387432238806863891521389491338949143897875391457339179883926973393005139396543939655393965639425353946255394625639593203959321396592639820533982055399780740056274011372402378540295024033716403572440389454043942405166840562444063177407085040771074083933409591341008984116099412580541309994138977414243941510564156645415998241638474176241418048041962694197611420136842048094213414423395642472884254229
- Lot Numbers
70 of 70 codes
386824838682823868283386828438806893880690388069138978733911425393001739311463939677393967839396793946226395576639820563982057399780840011284005629401137340185124035725404196440480304051618405624940719674080800408930440968444105260411909541258134130979413613441456904151049415995741638284171584417935142048104212769421870242339574254230426006542832354289476429216443278904327923432822143298274329833433421843443414351227
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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