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Class 2 Device Recall Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube |
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Date Initiated by Firm |
February 09, 2017 |
Create Date |
March 14, 2017 |
Recall Status1 |
Terminated 3 on June 20, 2018 |
Recall Number |
Z-1465-2017 |
Recall Event ID |
76433 |
510(K)Number |
K083641
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Product Classification |
Tube tracheostomy and tube cuff - Product Code JOH
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Product |
Bivona¿ 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
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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.
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FDA Determined Cause 2 |
Labeling False and Misleading |
Action |
Consignees 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 Commerce |
142 |
Distribution |
US: 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 Cycle |
TPLC Device Report
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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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510(K) Database |
510(K)s with Product Code = JOH and Original Applicant = SMITHS MEDICAL ASD, INC.
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