PL100-2oz
XR, LLC · Model PA Passion Lube Water Based 2oz · UDI-DI 00848518063229
10
510(k) clearances
171
Adverse events (1 deaths)
7
Recalls
124
Facilities
Description
Passion Natural Water-Based Lubricant - Lube Water Based 2oz Passion Natural Water Based Lubricant 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 polyisoprene condoms. This product is not compatible with natural rubber latex 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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Get your free API keyRead the docsData 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.