Z-1465-2017 Class II Terminated
FDA device recall Z-1465-2017 was initiated by Smiths Medical ASD Inc. on February 9, 2017 and is designated Class II. Reason for recall: Smiths Medical became aware that one lot of the Bivona¿ 3.5mm TTS Cuffed Pediatric tracheostomy tubes was incorrectly labeled for neonatal use instead of correctly labeled for pediatric use. The recall status is terminated (terminated June 20, 2018). Affected quantity: 142.
Recall Details
- Product Type
- Devices
- Report Date
- March 22, 2017
- Initiation Date
- February 9, 2017
- Termination Date
- June 20, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 142
Product Description
Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
Reason for Recall
Smiths Medical became aware that one lot of the Bivona¿ 3.5mm TTS Cuffed Pediatric tracheostomy tubes was incorrectly labeled for neonatal use instead of correctly labeled for pediatric use.
Distribution Pattern
US: CA, ILM NC, GA, NE, MA, CO, CT, MO, TN, LA, MD, MN, FL, SC,M OK, MI, PA, TX, WA, WI.
Code Information
3272963