Reported Jun 13, 2018 · Terminated
Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Smiths Medical ASD Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
- Bivona¿ Tracheostomy Tube Tracheostomy Tubes
- Lot codes and dates
Part No. (Lot No.): CMZ3241N (DS009716)ST16EN80NSC194N (DS009794)SU15AN70NSC153N (DS009577)FT17IN60NGC114N (DS009894)CMZ3331N (DS009761)XU17GS50NSF046N (DS009609)FT17IN60NGC114N (DS009861)AA16ES70NSC110N (DS009586)FT17IN70NSC111N (DS009856)FT16IN60NGC053N (DS009540)FU15AN55NSA076N (DS009464)AT17IS60NGC105N (DS009811)
- Amount recalled
- 16 units
Where it was sold
Why it was recalled
Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
This product could cause temporary or reversible health problems — stop using it.
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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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