Mcneil-Ppc, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
- FDA recalls
- 4
At a glance
Market reach
- United States
- FDA recalls
What Mcneil-Ppc, Inc. makes
McNeil-PPC, Inc. manufactures personal lubricants, including massage creams with warming or tingling sensations, and intimate mist sprays. Their portfolio also includes disposable feminine hygiene products, such as tampons.
These products are classified as Class II medical devices in the U.S. and are authorised via the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
K-Y Brand Intrigue 2-In-1 Massage Creme Ref K081236
Regimes: 510(k) Registry: 510(k)K-Y Brand Intrigue Intense Warming Sensation Ref K072360
Regimes: 510(k) Registry: 510(k)K-Y Brand Sensual Mist Ref K053397
Regimes: 510(k) Registry: 510(k)K-Y Brand Yours+mine Ref K072421
Regimes: 510(k) Registry: 510(k)O.B. Tampons Ref K023789
Regimes: 510(k) Registry: 510(k)K-Y Brand Touch Massage 2-In-1 Tingling Ref K062535
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 4 recalls initiated by Mcneil-Ppc, Inc., the earliest on 2012-07-02 and the most recent on 2013-01-25. By recorded status: 4 terminated. The reasons filed fall into these groups: mechanical integrity and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 25 Jan 2013 Z-0873-2013 Class II Terminated This product is not cleared for marketing in the US.
- 25 Jan 2013 Z-0874-2013 Class II Terminated This product is not cleared for marketing in the US.
- 25 Jan 2013 Z-0875-2013 Class II Terminated This product is not cleared for marketing in the US.
2012
- 2 Jul 2012 Z-2467-2012 Class II Terminated Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA concerns that the product should have been cleared under a separate medical device application. This voluntary recall is not being conducted on the basis of any consumer safety or product performance issues related to K-Y LIQUIBEADS. JJHP received a Warning Letter on May 23, 2012 indicating that thi
Frequently asked questions
How many devices does Mcneil-Ppc, Inc. have in the registry?
The registry currently lists 6 devices for Mcneil-Ppc, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mcneil-Ppc, Inc.'s devices?
Among its 6 most recently registered devices, Mcneil-Ppc, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Mcneil-Ppc, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Mcneil-Ppc, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Mcneil-Ppc, Inc.?
FDA recall records list 4 recalls initiated by Mcneil-Ppc, Inc., the most recent initiated on 25 Jan 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 Mcneil-Ppc, Inc. in the registry?
The most recently registered devices listed for Mcneil-Ppc, Inc. include K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME, K-Y BRAND INTRIGUE INTENSE WARMING SENSATION, K-Y BRAND SENSUAL MIST and K-Y BRAND YOURS+MINE.