Date Initiated by Firm |
May 14, 2021 |
Create Date |
July 01, 2021 |
Recall Status1 |
Terminated 3 on June 09, 2023 |
Recall Number |
Z-1993-2021 |
Recall Event ID |
87983 |
510(K)Number |
K041348
|
Product Classification |
Tube tracheostomy and tube cuff - Product Code JOH
|
Product |
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. |
Code Information |
Lot Number 4072715 |
Recalling Firm/ Manufacturer |
Smiths Medical ASD Inc. 6000 Nathan Ln N Minneapolis MN 55442-1690
|
For Additional Information Contact |
Dave Halverson 763-383-3310
|
Manufacturer Reason for Recall |
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.
|
FDA Determined Cause 2 |
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 in Commerce |
40 units |
Distribution |
US Nationwide distribution in the states of PA, MI, MD, FL. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = JOH and Original Applicant = SMITHS MEDICAL
|