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Important Information Regarding Bivona Tracheostomy Tube Supply

The following letter was provided to Wave Healthcare by Smith Medical. Wave Healthcare is committed to providing you with information about the current supply chain situation and will continue to share the most up-to-date information as it is received.

For questions, please reach out to your respiratory therapist or contact us at 866-935-9283 (WAVE).

17th February 2022

Bivona Tracheostomy Tube Supply

Dear Valued Customer,

On January 6, 2022, ICU Medical acquired Smiths Medical. We want to thank you and all our customers for the overwhelmingly positive response to the value and promise our combined portfolio of clinically relevant products brings to you and your patients. With that said, we recognize that the current supply situation with many Smiths Medical products is not meeting your expectations.

This past year has seen unprecedented challenges within global supply chains on key raw materials used in the manufacture and packaging of many products. The purpose of this communication is to inform you of the impact of raw material shortages on the supply of Bivona tracheostomy products. These shortages are impacting our production and have prompted us to place the Bivona products on allocation.

Smith Medical recognizes the significant impact and role Bivona products have in patient care, and we are undertaking mitigation measures, including communications with government agencies to minimize disruptions. Our commitment to addressing supply issues is a commitment to keeping you informed of our progress.

Thank you for your patience and understanding. As a reminder, our Bivona tracheostomy tubes can be reprocessed up to 10 times for adult tubes and up to 5 times for neonatal and pediatric tubes. Please refer to the instructions for use (IFU) for details.