Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Custom Made Tracheostomy Device The CADD Administration Sets with Flow Recalled by Smiths Medical ASD, Inc. Due to Smiths Medical determined that a single custom Tracheostomy...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Smiths Medical ASD, Inc. directly.
Affected Products
Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.
Quantity: 1
Why Was This Recalled?
Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
Where Was This Sold?
International Distribution to:Germany
About Smiths Medical ASD, Inc.
Smiths Medical ASD, Inc. has 114 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report