Tapemark Co.
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Tapemark Co. makes
Tapemark Co. manufactures intravascular catheter securement devices designed to stabilize catheters within blood vessels, reducing displacement risks during patient care.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Intravascular Catheter Securement Dev Ref K841487
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Tapemark Co., initiated on 2021-11-10. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use and packaging. 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 0
- 2019 0
- 2020 0
- 2021 1
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2021
- 10 Nov 2021 Z-0454-2022 Class III Terminated The dosage information on the pouch is incorrect; the primary carton label is correct.
Frequently asked questions
How many devices does Tapemark Co. have in the registry?
The registry currently lists 1 device for Tapemark Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tapemark Co.'s devices?
Among its 1 most recently registered device, Tapemark Co. has devices listed in FDA 510(k) (1 device).
What risk classes do Tapemark Co.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Tapemark Co.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Tapemark Co.?
FDA recall records list 1 recall initiated by Tapemark Co., the most recent initiated on 10 Nov 2021. 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 Tapemark Co. in the registry?
The most recently registered devices listed for Tapemark Co. include INTRAVASCULAR CATHETER SECUREMENT DEV.