Care Fusion 213, LLC
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Care Fusion 213, LLC makes
Care Fusion 213, LLC manufactures antimicrobial dressings, including the Chlorashield™ Antimicrobial Dressing, designed to reduce microbial contamination in wound care applications.
The company’s products are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Chlorashield Tm Antimicrobial Dressing Ref K103106
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Care Fusion 213, LLC, initiated on 2013-03-04. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 4 Mar 2013 Z-1001-2013 Class III Terminated An internal review of CareFusion's labeling for preoperative skin prep product codes was recently conducted. The labeling of the product codes identified above state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized.
Frequently asked questions
How many devices does Care Fusion 213, LLC have in the registry?
The registry currently lists 1 device for Care Fusion 213, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Care Fusion 213, LLC's devices?
Among its 1 most recently registered device, Care Fusion 213, LLC has devices listed in FDA 510(k) (1 device).
Are there FDA recall records for Care Fusion 213, LLC?
FDA recall records list 1 recall initiated by Care Fusion 213, LLC, the most recent initiated on 4 Mar 2013. 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 Care Fusion 213, LLC in the registry?
The most recently registered devices listed for Care Fusion 213, LLC include CHLORASHIELD TM ANTIMICROBIAL DRESSING.