Summary
The FDA issued a Class II for Thoraguard Chest Tube Kit, 20 Fr by Centese Inc.. Reason: An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak..
Details
Source
Device Recall
External ID
Z-0105-2022
Action Date
2021-10-20
Status
Terminated
Category
device
Product Description
Thoraguard Chest Tube Kit, 20 Fr
Lot/Code Info: Model: FGS-1126 Catalog Number: TGCT120020 Lot Numbers 20100102, 21031703, and 21053102
Quantity Affected: 310 kits
Reason for Recall
An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak.
Distribution
Distribution to a single consignee located in California.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-31
Company
Omaha, NE
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 174 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Centese Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Centese Inc. have FDA actions?
This is the only FDA action we have on record for Centese Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0105-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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