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U.S. Department of Health and Human Services

Class 2 Device Recall Bivona Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube

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  Class 2 Device Recall Bivona Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube see related information
Date Initiated by Firm January 18, 2021
Create Date February 23, 2021
Recall Status1 Open3, Classified
Recall Number Z-1145-2021
Recall Event ID 87192
510(K)Number K944178  
Product Classification Tube tracheostomy and tube cuff - Product Code JOH
Product Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) V Neck Flange 4.5mm - Product Usage: intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed for single-patient use up to 5 times.
Code Information model 60PFS45, lots 3991171 (202 units), 3991172 (117 units), and 3988103 (229 units).
Recalling Firm/
Manufacturer
Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
Manufacturer Reason
for Recall
Smiths Medical became aware that three lot numbers of a specific model of Bivona¿ Cuffless FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) may have been incorrectly packaged with a straight neck flange instead of a V-neck flange. As a result, there is potential for patient injury if an incorrect device or accessory is selected for use. This use could lead to an internal injury resulting from excessive device contact with tissue, or an external patient injury due to external portions of the device pressing into or rubbing against tissue.
FDA Determined
Cause 2
Under Investigation by firm
Action Distribution of the "URGENT MEDICAL DEVICE RECALL NOTICE" dated 01/29/2021 during the week of January 18, 2021.
Quantity in Commerce 548 units
Distribution US Nationwide distribution including in the states of AL, AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TX, UT, VA, and WA.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JOH and Original Applicant = BIVONA MEDICAL TECHNOLOGIES
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