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U.S. Department of Health and Human Services

Class 2 Device Recall Bivona Tracheostomy Tube Tracheostomy Tubes

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  Class 2 Device Recall Bivona Tracheostomy Tube Tracheostomy Tubes see related information
Date Initiated by Firm April 02, 2018
Create Date June 07, 2018
Recall Status1 Terminated 3 on November 14, 2018
Recall Number Z-2114-2018
Recall Event ID 80092
Product Classification Tube, tracheostomy (w/wo connector) - Product Code BTO
Product Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Code Information 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)  
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact
763-383-3072
Manufacturer Reason
for Recall		 Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
FDA Determined
Cause 2		 Error in labeling
Action 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.
Quantity in Commerce 16 units
Distribution Domestic distribution to CA, FL, GA, ID, NJ, NM, OH, VA. International distribution to France.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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