Bivona Tracheostomy Tube Tracheostomy Tubes
Hazard
Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
What You Should Do
Remedy
Customers were notified via letter on approximately 04/02/2018. Instructions included to determine if there are any affected Customized Bivona Tracheostomy Tubes in inventory, notify customers if the devices have been further distributed, arrange for the return of affected devices, and complete and return the acknowledgement response form.
Affected by this recall?
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Products
Bivona Tracheostomy Tube Tracheostomy Tubes
- Brand
- Smiths Medical ASD Inc.
- UPC
- 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)
Units Affected
16 units