Tube Tracheostomy And Tube Cuff（JOH）

Due to customer complaint regarding incorrect display box labeling.

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death.

The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).

There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This resulted in an unsecure connection between the device connector and circuit components, cap, or accessories.

There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This resulted in an unsecure connection between the device connector and circuit components, cap, or accessories.

A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure connection could lead to respiratory failure, dyspnea, treatment delay, tissue injury, or bleeding.

One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit.

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.

A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.

Label has the incorrect size for the tracheotomy tube.

One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.

Smiths Medical became aware that one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy Tube kit, product reorder number 100/897/080 CZ, lot number 3308971, contains an incorrect 9.0mm sized obturator instead of the correct 8.0mm sized obturator.

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.

The connector may disconnect from the tracheostomy tube during use.

Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.

Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels.