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U.S. Department of Health and Human Services

Class 2 Device Recall Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube

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 Class 2 Device Recall Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tubesee related information
Date Initiated by FirmFebruary 09, 2017
Create DateMarch 14, 2017
Recall Status1 Terminated 3 on June 20, 2018
Recall NumberZ-1465-2017
Recall Event ID 76433
510(K)NumberK083641 
Product Classification Tube tracheostomy and tube cuff - Product Code JOH
ProductBivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
Code Information 3272963
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
Manufacturer Reason
for Recall		Smiths Medical became aware that one lot of the Bivona 3.5mm TTS Cuffed Pediatric tracheostomy tubes was incorrectly labeled for neonatal use instead of correctly labeled for pediatric use.
FDA Determined
Cause 2		Labeling False and Misleading
ActionConsignees were sent a Smiths Medical "Urgent Medical Device Field Safety Notice" dated February 08, 2017. The letter was addressed to "Clinician". The letter listed the Affected devices, Reason for Recall, Risk to Health, and Instructions to Customers. Advised customers to complete and return the "Urgent Medical Device Field Safety Notice (FSN) Response Form" to smithsmedical4390@stericycle.com. All affected devices must be returned to Stericycle for processing. If the product was further distributed, consignees were asked to immediately notify them of the Recall and retrieve all affected devices. For questions contact Stericycle via e-mail at the following address: smithsmedical4390@stericycle.com.
Quantity in Commerce142
DistributionUS: CA, ILM NC, GA, NE, MA, CO, CT, MO, TN, LA, MD, MN, FL, SC,M OK, MI, PA, TX, WA, WI.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = JOH
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