Recall Z-1145-2021 ยท JOH Tube Tracheostomy And Tube Cuff
Smiths Medical ASD Inc.
Tube Tracheostomy and Tube Cuff, Bivona Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) V Neck Flange 4.5mm - Product Usage: intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed for single-patient use up to 5 times.
| Date | Jan 18, 2021 |
| Status | Terminated |
| Reason | Smiths Medical became aware that three lot numbers of a specific model of Bivona Cuffless FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) may have been incorrectly packaged with a straight neck flange instead of a V-neck flange. As a result, there is potential for patient injury if an incorrect device or accessory is selected for use. This use could lead to an internal injury resulting from excessive device contact with tissue, or an external patient injury due to external portions of the device pressing into or rubbing against tissue. |
| Root cause | Under Investigation by firm |
| Action | Distribution of the "URGENT MEDICAL DEVICE RECALL NOTICE" dated 01/29/2021 during the week of January 18, 2021. |
| Quantity | 548 units |
| Distribution | US Nationwide distribution including in the states of AL, AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TX, UT, VA, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944178 | BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES Bivona Medical Technologies, Oct 27, 1994 |