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U.S. Department of Health and Human Services

Class 2 Device Recall Thoraguard Chest Tube Kit

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  Class 2 Device Recall Thoraguard Chest Tube Kit see related information
Date Initiated by Firm August 31, 2021
Create Date October 13, 2021
Recall Status1 Terminated 3 on August 07, 2023
Recall Number Z-0105-2022
Recall Event ID 88616
Product Classification Catheter, irrigation - Product Code GBX
Product Thoraguard Chest Tube Kit, 20 Fr
Code Information Model: FGS-1126 Catalog Number: TGCT120020 Lot Numbers 20100102, 21031703, and 21053102
Recalling Firm/
Manufacturer		 Centese Inc.
4156 S 52nd St
Omaha NE 68117-1324
Manufacturer Reason
for Recall		 An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak.
FDA Determined
Cause 2		 Under Investigation by firm
Action The impacted consignee was notified via email of the recall on 08/31/2021. The customer has been instructed to immediately cease product use and return all impacted product to the recalling firm.
Quantity in Commerce 310 kits
Distribution Distribution to a single consignee located in California.
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.
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