Bivona¿ Tracheostomy Tube Tracheostomy Tubes recall: Labeling Error
Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Why was Bivona¿ Tracheostomy Tube Tracheostomy Tubes recalled?
Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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)
- Product
- Bivona¿ Tracheostomy Tube Tracheostomy Tubes
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 16 units
- Distribution
- Domestic distribution to CA, FL, GA, ID, NJ, NM, OH, VA. International distribution to France.
- Recall date
- June 13, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)