Recall Z-1465-2017 ยท JOH Tube Tracheostomy And Tube Cuff
Smiths Medical ASD Inc.
Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
| Date | Feb 9, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling False and Misleading |
| Action | Consignees were sent a Smiths Medical "Urgent Medical Device Field Safety Notice" dated February 08, 2017. The letter was addressed to "Clinician". The letter listed the Affected devices, Reason for Recall, Risk to Health, and Instructions to Customers. Advised customers to complete and return the "Urgent Medical Device Field Safety Notice (FSN) Response Form" to smithsmedical4390@stericycle.com. All affected devices must be returned to Stericycle for processing. If the product was further distributed, consignees were asked to immediately notify them of the Recall and retrieve all affected |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083641 | BIVONA TRACHEOSTOMY TUBES Smiths Medical Asd, Inc., Feb 23, 2009 |