Lansinoh Laboratories
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Lansinoh Laboratories makes
Lansinoh Laboratories manufactures a compact wearable insulin pump designed for continuous subcutaneous insulin infusion, intended for diabetes management.
The device is classified as Class II under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Compact Wearable Pump Ref K230469
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Lansinoh Laboratories, initiated on 2012-08-14. 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.
2012
- 14 Aug 2012 Z-0784-2013 Class II Terminated The Spanish translation on the Instructions for Use (IFU) insert and product package for hot and cold packs has incorrect heating instructions which would cause product to over heat.
Frequently asked questions
How many devices does Lansinoh Laboratories have in the registry?
The registry currently lists 1 device for Lansinoh Laboratories. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lansinoh Laboratories's devices?
Among its 1 most recently registered device, Lansinoh Laboratories has devices listed in FDA 510(k) (1 device).
What risk classes do Lansinoh Laboratories's devices fall under?
Among its 1 most recently registered device, the classes recorded for Lansinoh Laboratories's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Lansinoh Laboratories?
FDA recall records list 1 recall initiated by Lansinoh Laboratories, the most recent initiated on 14 Aug 2012. 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 Lansinoh Laboratories in the registry?
The most recently registered devices listed for Lansinoh Laboratories include Compact Wearable Pump.