Recall Z-1993-2021 ยท JOH Tube Tracheostomy And Tube Cuff
Smiths Medical ASD Inc.
PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel.
| Date | May 14, 2021 |
| Status | Terminated |
| Reason | One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit. |
| Root cause | Labeling mix-ups |
| Action | The firm initiated the recall by email on 05/14/2021. The notice requested the return of the units and distributors were directed to notify their customers. |
| Quantity | 40 units |
| Distribution | US Nationwide distribution in the states of PA, MI, MD, FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041348 | PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA Smiths Medical, Jul 13, 2004 |