Conseal International, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Conseal International, Inc. makes
Conseal International, Inc. manufactures Mendasil TWG Gel, an antimicrobial skin and wound gel designed to prevent microbial contamination and support wound healing.
The product is classified as Class II under FDA regulations and is listed via a 510(k) clearance in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Conseal International, Inc., initiated on 2018-04-25. By recorded status: 1 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 25 Apr 2018 Z-1627-2018 Class II Terminated A recent FDA inspection of the firm revealed significant Current Good Manufacturing Practices (cGMP) deficiencies including lack of data to support products conform to final specifications, and lack of expiration dates on the product being recalled.
Frequently asked questions
How many devices does Conseal International, Inc. have in the registry?
The registry currently lists 1 device for Conseal International, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Conseal International, Inc.'s devices?
Among its 1 most recently registered device, Conseal International, Inc. has devices listed in FDA 510(k) (1 device).
Are there FDA recall records for Conseal International, Inc.?
FDA recall records list 1 recall initiated by Conseal International, Inc., the most recent initiated on 25 Apr 2018. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Conseal International, Inc. in the registry?
The most recently registered devices listed for Conseal International, Inc. include MENDASIL TWG GEL ANTIMICROBIAL SKIN AND WOUND GEL.