Global Healthcare, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Global Healthcare, Inc. makes
Global Healthcare, Inc. manufactures self-sealing sterilization pouches for medical instruments, surgical apparel designed for operating room use, and disposable face masks for clinical and procedural settings.
These products are classified as Class II devices under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Surgical Apparel Ref K954549
Regimes: 510(k) Registry: 510(k)Global Healthcare Face Mask Ref K953754
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Global Healthcare, Inc., the earliest on 2016-01-06 and the most recent on 2016-08-09. By recorded status: 2 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 9 Aug 2016 Z-2870-2016 Class II Terminated The multi-sample needle retractable sheath may not fully retract over the needle during the changes of the blood collection tubes.
- 6 Jan 2016 Z-0696-2016 Class II Terminated Firm was notified of a potential product defect related to kinking (flattening) of anesthesia extension tubes which may represent a potential health hazard.
Frequently asked questions
How many devices does Global Healthcare, Inc. have in the registry?
The registry currently lists 3 devices for Global Healthcare, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Global Healthcare, Inc.'s devices?
Among its 3 most recently registered devices, Global Healthcare, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Global Healthcare, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Global Healthcare, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Global Healthcare, Inc.?
FDA recall records list 2 recalls initiated by Global Healthcare, Inc., the most recent initiated on 9 Aug 2016. 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 Global Healthcare, Inc. in the registry?
The most recently registered devices listed for Global Healthcare, Inc. include GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH, SURGICAL APPAREL and GLOBAL HEALTHCARE FACE MASK.