TroClose 1200 - Product Usage: intended for use in a recall: Endotoxin
TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and urologic endoscopic procedures, to create and maintain a port…
Why was TroClose 1200 - Product Usage: intended for use in a recalled?
Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).
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?
Catalog Number: GSTC1200 Lot Numbers: AS200009/3, Exp 14 FEB 2022 AS200012/4, Exp 23 MAR 2022
- Product
- TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and urologic endoscopic procedures, to create and maintain a port…
- Recalling firm
- Gordian Surgical
- Quantity
- 300 total devices
- Distribution
- US Nationwide distribution including in the states of Texas and Michigan.
- Recall date
- November 11, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)