PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP60
This recall is currently active, issued August 23, 2024. It was issued by Smiths Medical Asd Inc..
- Company
- Smiths Medical Asd Inc.
- Recall Initiated
- May 29, 2024
- Posted
- August 23, 2024
- Recall Number
- Z-2611-2024
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution.
Lot / Code Info
a) UDI/DI 10351688518491, Product Code/List Number/Item Code 67PFP40, Lot Numbers: 3868327, 3880710, 3918015, 3930013, 3942484, 3952350, 4035694, 4096834, 4134018, 4185407, 4240126, 4334895, 4348414, 4388111; b) UDI/DI 10351688518507, Product Code/List Number/Item Code 67PFP45, Lot Numbers: 3864223, 3880709, 3894903, 3920941, 3939673, 3959299, 4035696, 4063166, 4086000, 4334896, 4348416, 4357247; c) UDI/DI 10351688518514, Product Code/List Number/Item Code 67PFP50, Lot Numbers: 3853394, 3877669, 3897878, 3914570, 3923744, 3930055, 3936567, 3936568, 3981982, 4005587, 4026685, 4043939, 4066291, 4105261, 4119098, 4138983, 4156623, 4176226, 4328213, 4334900, 4400630; d) UDI/DI 10351688518521, Product Code/List Number/Item Code 67PFP55, Lot Numbers: 3871036, 3897866, 3923732, 3942524, 3952396, 3962591, 4035697, 4083921, 4096842, 4145687, 4159967, 4171576, 4237354, 4331568, 4352769, 4374408, 4383601, 4395748; e) UDI/DI 10351688518538, Product Code/List Number/Item Code 67PFP60, Lot Numbers: 3802151, 3828304, 3853395, 3864250, 3877668, 3887728, 3901296, 3917990, 3917991, 3930054, 3939650, 3946263, 3955813, 3955814, 3962593, 3987942, 4001127, 4023778, 4029494, 4035699, 4038943, 4043940, 4051663, 4056250, 4060222, 4071968, 4083920, 4086014, 4095924, 4107601, 4128029, 4151057, 4161985, 4168164, 4176242, 4237355, 4328214, 4331569, 4334902, 4388112
Root Cause
Under Investigation by firm
Action Taken
Smiths 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