MMSClass I
Lubricant, Vaginal, Patient
General Hospital · 21 CFR 880.6375
MDR events12All time
Recalls2All time
Registered firms4Currently listed
510(k) clearances0All time
Recent MDR events
12 adverse event reports on file
- ASTROGLIDE ULTRA GENTLE GEL PERSONAL LUBRICANTJul 31, 2019InjuryBiofilm, Inc.MW5088567
- K-Y TOUCH MASSAGE 2 IN 1 WARMINGApr 10, 2012InjurySkillman Contract2214133-2012-00011
- K-Y TOUCH MASSAGE 2 IN 1 WARMING USAAug 4, 2011InjurySkillman Contract2214133-2011-00003
- EXCITEDec 1, 2010OtherAnsell Protective Products, Inc.MW5018977
- K-Y TOUCH MASSAGE 2 IN 1 WARMINGJun 28, 2010InjuryJ & J Healthcare Products2214133-2010-00007
- REPHRESH VAGINAL GELAug 26, 2009OtherLil Drug Store Products, Inc.3003491851-2009-00001
- K-Y WARMING ULTRAGELJan 4, 2007OtherKik Customs Products2214133-2007-00001
- Unnamed deviceJan 4, 2007Injury9615332-2007-00001
- KY WARMING ULTRA GELJul 27, 2005*MW4003980
- K-Y WARMING LIQUIDApr 1, 2005OtherPersonal Products Co.2214133-2005-00002
Event type breakdown
Injury6
Other4
Unspecified1
Death1
Recalls
2 recall events for this product code
- Mckesson Medical-Surgical Inc. Corporate OfficeOpen, ClassifiedAug 26, 2022
FISHER SCIENTIFIC Aseptic Control LUBRICATING JELLY PAP TEST 4OZ(12/PK)
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1628-2022 · View FDA record ↗ - Sheffield Pharmaceuticals, LLCTerminatedJul 2, 2015
Dr. Sheffield's LUBRI GEL 3 oz (85 g)
Recovery of high count of gram positive rods including single colonies of B. cepacia.
Z-1953-2015 · View FDA record ↗
Registered firms
4 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.