FDA Recall
Terminated
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.
Recall: Z-1993-2021
·
Initiated May 14, 2021
Recall
- Recall Number
- Z-1993-2021
- Event Number
- 87983
- Firm
- Smiths Medical ASD Inc.
- FEI Number
- 3012307300
- Product Code
- JOH
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- May 14, 2021
- Terminated
- June 9, 2023
- Address
- 6000 Nathan Ln N, Minneapolis, MN, 55442-1690
Description
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.
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.
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.
Distribution
US Nationwide distribution in the states of PA, MI, MD, FL.
Quantity
40 units