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
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Product | Thoraguard Chest Tube Kit, 20 Fr |
Code Information |
Model: FGS-1126
Catalog Number: TGCT120020
Lot Numbers 20100102, 21031703, and 21053102
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Recalling Firm/ Manufacturer |
Centese Inc. 4156 S 52nd St Omaha NE 68117-1324
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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 |
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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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