Z-0577-2018 Class II Terminated
FDA device recall Z-0577-2018 was initiated by Smiths Medical ASD, Inc. on Jul 15, 2016 and is designated Class II. Reason for recall: Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization. The recall status is terminated (terminated Apr 24, 2020). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 21, 2018
- Initiation Date
- Jul 15, 2016
- Termination Date
- Apr 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
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.
Distribution Pattern
International Distribution to:Germany
Code Information
GS025081
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0577-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026