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Bivona recallZ-2608-2024 · Smiths Medical ASD Inc. · initiated May 29, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smiths Medical ASD Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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 [email protected] 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 [email protected]" Questions: Global Complaint Management - 1-(866)-216-8806 or US: [email protected] Customer Service: [email protected] or 1-(800)-258-5361

Recall details

Recall number
Z-2608-2024
Status
Open, Classified
Initiated by the company
May 29, 2024
Posted by the FDA
Aug 23, 2024
Recalling firm
Smiths Medical ASD Inc.
Product code
BTO
FDA submissions
K912469
Distribution
Worldwide distribution.

Product description

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP40

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

a) UDI/DI 10351688518736, Product Code/List Number/Item Code 67NFP25, Serial Numbers: 3936586, 4033699, 4091401, 4334881; b) UDI/DI 10351688518743, Product Code/List Number/Item Code 67NFP30, Serial Numbers: 3853379, 3864236, 3874314, 3884252, 3901302, 3930043, 3955792, 3962588, 3997790, 4011356, 4033700, 4063161, 4097823, 4116100, 4145705, 4163839, 4331551, 4334882, 4374402, 4380994; c) UDI/DI 10351688518750, Product Code/List Number/Item Code 67NFP35, Serial Numbers: 3853380, 3874302, 3891535, 3923730, 3939680, 3952399, 3959334, 4001123, 4021415, 4086018, 4110430, 4130984, 4151052, 4176229, 4218691, 4237346, 4331592, 4333982, 4357246, 4383594, 4388098, 4395737; d) UDI/DI 10351688518767Product Code/List Number/Item Code 67NFP40, Serial Numbers: 3853381, 3861138, 3894884, 3923727, 3952393, 3987930, 4033701, 4083924, 4122439, 4156634, 4237348, 4334883, 4388099

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

26 devices cleared under K912469 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94852).

Sources and updates

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