Health product recall

Niti-S Bronchial Uncovered Stent [Both Flare Type]

Last updated

Summary

Product
Niti-S Bronchial Uncovered Stent [Both Flare Type]
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Niti-S Bronchial Uncovered Stent [Both Flare Type] 21E1330AABR024 20G0629BBBR016 21J4136BBBR015 21L3221BKBR017 20E5694AKBR011 BR1404W BR1204W

Issue

Some of the specifications for the Niti-S Bronchial Uncovered Stent [Both Flare Type]  (BRxxxxW) do not meet the company's standards.  There is a possibility that some of these devices within the expiration date (3 years from manufacturing date) may not perform as intended due to the under performance of expansion and compression.

Recall Start Date: March 14, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies

Taewoong Medical Co.,Ltd.

14 Gojeong-Ro, Wolgot-Myeon, Gimpo-Si, South Korea, 10022

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75374

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