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Satin Gel Vitamin E human lubricant

Shenzhen Yongquan Medical Devices Co., Ltd. · Model 200ml · UDI-DI 06977552380574

NUC

510(k) clearances

175

Adverse events (1 deaths)

Recalls

125

Facilities

Description

Satin Gel with Vitamin E is a long lasting, exquisitely textured, clearwater-based lubricant, designed to enhance your intimate pleasure. Themodem update of the original Satin Gel formula. Excellent to supplementyour natural lubrication before or during sex. As with all products, ifiritation occurs, discontinue use, if it persists, consult a doctor. Forfabrics, soak in plain water then rinse thoroughly before a normal coldwash. Sponge out of carpet with plain water. Very slippery if spilled, soclean up immediately. Store in a clean, dry place at room temperature.

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.