Ansell Healthcare, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Ansell Healthcare, Inc. makes
Ansell Healthcare, Inc. manufactures liquid personal lubricants under the Lifestyles brand and large condoms available for Lifestyles, Contempo, or private-label distribution.
These products are classified as Class II medical devices and are listed in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
Lifestyles Liquid Personal Lubricant Ref K033076
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Ansell Healthcare, Inc., initiated on 2002-11-25. 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.
2002
- 25 Nov 2002 Z-0401-03 Unclassified (pre-2012) Terminated The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards
- 25 Nov 2002 Z-0402-03 Unclassified (pre-2012) Terminated The condoms are being recalled because information recently available indicates some of these condoms do not meet airburst test standards
Frequently asked questions
How many devices does Ansell Healthcare, Inc. have in the registry?
The registry currently lists 2 devices for Ansell Healthcare, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ansell Healthcare, Inc.'s devices?
Among its 2 most recently registered devices, Ansell Healthcare, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Ansell Healthcare, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ansell Healthcare, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Ansell Healthcare, Inc.?
FDA recall records list 2 recalls initiated by Ansell Healthcare, Inc., the most recent initiated on 25 Nov 2002. 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 Ansell Healthcare, Inc. in the registry?
The most recently registered devices listed for Ansell Healthcare, Inc. include LIFESTYLES LIQUID PERSONAL LUBRICANT and LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM.