FDAFDA · Food and drugs·Recall number Z-1465-2017
Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
Published March 22, 2017 · Recall initiated: February 9, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smiths Medical ASD Inc.
- Distributor
- US: CA, ILM NC, GA, NE, MA, CO, CT, MO, TN, LA, MD, MN, FL, SC,M OK, MI, PA, TX, WA, WI.
- Lot
- 3272963
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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