FDAClass IIOctober 20, 2021

Thoraguard Chest Tube Kit recall

Thoraguard Chest Tube Kit, 20 Fr

Why was Thoraguard Chest Tube Kit recalled?

An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model: FGS-1126 Catalog Number: TGCT120020 Lot Numbers 20100102, 21031703, and 21053102

Product
Thoraguard Chest Tube Kit, 20 Fr
Recalling firm
Centese Inc.
Quantity
310 kits
Distribution
Distribution to a single consignee located in California.
Recall date
October 20, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls