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U.S. Department of Health and Human Services

Class 1 Device Recall Bivona AireCuf, TTS", FlexTend"

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 Class 1 Device Recall Bivona AireCuf, TTS", FlexTend"see related information
Date Initiated by FirmMay 29, 2024
Date PostedAugust 23, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2607-2024
Recall Event ID 94852
510(K)NumberK912469 
Product Classification Tube, tracheostomy (w/wo connector) - Product Code BTO
ProductPORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Item Code 67N040
Code Information UDI/DI 15021312006230, Product Code/List Number/Item Code 67N040, Serial Numbers: 3877658, 3901313, 3923737, 3936563, 3942521, 3965334, 4016051, 4331550, 4334880, 4352757, 4362870, 4369535, 4380068
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information ContactGlobal Complaint Management
866-216-8806
Manufacturer Reason
for Recall		Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
FDA Determined
Cause 2		Under Investigation by firm
ActionSmiths Medical issued an URGENT MEDICAL DEVICE NOTIFICATION to its consignees on 05/29/2024 via letter. The notice explained the issue with the device, potential risk and requested the following: "Customer Required Actions: When using the device, all instructions, including warning and cautions contained in the Instructions for Use Documentation must be followed with heightened awareness. Please complete the following actions listed below: 1. Check all inventory locations within your institution for the affected catalog numbers listed in the notification and discontinue use. Discard all affected products following your institution s process for discarding. If discarding is not immediately possible at your facility, then the product should be quarantined until disposal. 2. Share this notification with all potential users of the devices to ensure they are aware of this notification and proposed mitigations. If the devices are used at another location, please ensure this communication is delivered there. 3. Complete and return the attached Customer Response Form to smithsmedical3513@sedgwick.com within 10 days of receipt to acknowledge your understanding of this notification. Please contact your local representative for assistance with replacement product and/or credit. 3. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to smithsmedical3513@sedgwick.com" Questions: Global Complaint Management - 1-(866)-216-8806 or US: globalcomplaints@icumed.com Customer Service: Customerservice@icumed.com or 1-(800)-258-5361
DistributionWorldwide distribution.
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 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) Database510(K)s with Product Code = BTO
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