Recall Z-0577-2018— Smiths Medical ASD, Inc.
Class II · Terminated
Class II FDA medical device recall by Smiths Medical ASD, Inc., initiated 2016-07-15, terminated 2020-04-24. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization..
- Recalling firm
- Smiths Medical ASD, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-07-15
- Terminated
- 2020-04-24
- Firm location
- Gary, IN, United States
Product description
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.
Reason for recall
Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
Data sourced from openFDA. This site is unofficial and independent of the FDA.