Recall Z-2114-2018— Smiths Medical ASD Inc.
Class II · Terminated
Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2018-04-02, terminated 2018-11-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Bivona¿ Tracheostomy Tube Tracheostomy Tubes. Reason: Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile..
- Recalling firm
- Smiths Medical ASD Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-02
- Terminated
- 2018-11-14
- Firm location
- Minneapolis, MN, United States
Product description
Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Reason for recall
Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
Data sourced from openFDA. This site is unofficial and independent of the FDA.