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U.S. Department of Health and Human Services

Class 2 Device Recall PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit

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 Class 2 Device Recall PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kitsee related information
Date Initiated by FirmMay 14, 2021
Create DateJuly 01, 2021
Recall Status1 Terminated 3 on June 09, 2023
Recall NumberZ-1993-2021
Recall Event ID 87983
510(K)NumberK041348 
Product Classification Tube tracheostomy and tube cuff - Product Code JOH
ProductPORTEX 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 ContactDave 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
ActionThe 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 Commerce40 units
DistributionUS Nationwide distribution in the states of PA, MI, MD, FL.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JOH
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