Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
Reported: March 22, 2017 Initiated: February 9, 2017 #Z-1465-2017
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.
Details
- Recalling Firm
- Smiths Medical ASD Inc.
- Units Affected
- 142
- Distribution
- US: CA, ILM NC, GA, NE, MA, CO, CT, MO, TN, LA, MD, MN, FL, SC,M OK, MI, PA, TX, WA, WI.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Bivona¿ TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.. Recalled by Smiths Medical ASD Inc.. Units affected: 142.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 22, 2017. Severity: Moderate. Recall number: Z-1465-2017.
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