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Maude - Shine Silicone Personal Lubricant 2oz

Maude Group, Inc. · Model 55761 · UDI-DI 00860773000474

NUC

510(k) clearances

171

Adverse events (1 deaths)

Recalls

124

Facilities

Description

This is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Recalls

Date	Firm	Reason
2022-06-23	Family Dollar Stores, Llc.	Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
2013-01-25	Mc-NEIL-PPC, Inc.	This product is not cleared for marketing in the US.
2013-01-25	Mc-NEIL-PPC, Inc.	This product is not cleared for marketing in the US.
2013-01-25	Mc-NEIL-PPC, Inc.	This product is not cleared for marketing in the US.
2012-07-02	Mc-NEIL-PPC, Inc.	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
2009-07-10	Memphis Fertility Laboratory Inc	Product was marketed without a 510(k).
2008-09-22	INGfertility, LLC	Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci).

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.