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U.S. Department of Health and Human Services

Class 2 Device Recall smiths medical portex Tracheal Intubation Stylet

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  Class 2 Device Recall smiths medical portex Tracheal Intubation Stylet see related information
Date Initiated by Firm August 04, 2021
Create Date September 01, 2021
Recall Status1 Open3, Classified
Recall Number Z-2401-2021
Recall Event ID 88425
Product Classification Orotracheal intubation guide kit - Product Code OGK
Product smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
Code Information Lot 4015424
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact Mr. Dave Halverson
763-383-3310
Manufacturer Reason
for Recall		 The incorrect device is contained in the package.
FDA Determined
Cause 2		 Employee error
Action The letter dated 8/4/2021 was issued 8/4/2021 via tracked mail and requested return of the product.
Quantity in Commerce 1,590 units
Distribution International distribution was made to the countries of Canada, Japan, Indonesia, and Spain.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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