Z-2946-2020 Class II Terminated
FDA device recall Z-2946-2020 was initiated by Smiths Medical ASD Inc. on August 28, 2020 and is designated Class II. Reason for recall: Label has the incorrect size for the tracheotomy tube. The recall status is terminated (terminated May 13, 2021). Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 16, 2020
- Initiation Date
- August 28, 2020
- Termination Date
- May 13, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.
Reason for Recall
Label has the incorrect size for the tracheotomy tube.
Distribution Pattern
US Distribution to state of: CT
Code Information
Lot# 3952216