Z-2485-2020 Class II Terminated
FDA device recall Z-2485-2020 was initiated by Smiths Medical ASD Inc. on May 26, 2020 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated May 5, 2021). Affected quantity: 20 devices.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2020
- Initiation Date
- May 26, 2020
- Termination Date
- May 5, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 devices
Product Description
Pediatric Adjustable Flange Tracheostomy Tube Cuffless
Reason for Recall
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.
Distribution Pattern
U.S: NE, TN, TX, and MS. Worldwide: France, Sweden, United Arab Emirates, UK, Netherlands, Czechia, Australia and Denmark.
Code Information
Model Number: 60HA30, Lot: 3794165, SKU 60HA30