FDA-Device2017-03-22Class II
Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
Smiths Medical ASD Inc.
Hazard
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.
Sold states
US: CA, ILM NC, GA, NE, MA, CO, CT, MO, TN, LA, MD, MN, FL, SC,M OK, MI, PA, TX, WA, WI.
Affected count
142
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1465-2017Don't want to check this manually?
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