Kimberly-Clark Corporation

FDA Regulatory Profile

Summary

Total Recalls
19
510(k) Clearances
11
Inspections
6
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0319-2021Class IIScott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed in the U.S. by KimberlFebruary 1, 2021
Z-0748-2019Class IIU by Kotex¿ Sleek¿, Regular Tampons, 18 CountDecember 11, 2018
Z-0751-2019Class IIU by Kotex¿ Sleek¿, Regular Tampons, 3 CountDecember 11, 2018
Z-0749-2019Class IIU by Kotex¿ Sleek¿, Regular Tampons, 34 CountDecember 11, 2018
Z-0750-2019Class IIU by Kotex¿ Sleek¿, Regular/Super Tampons, 34 Count MultipackDecember 11, 2018
Z-0850-2014Class IIKimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, DistribOctober 29, 2013
Z-0518-2014Class IIKimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405October 24, 2013
Z-0995-2013Class IIKIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended tMarch 6, 2013
Z-0257-2013Class IIULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgiJuly 5, 2012
Z-0258-2013Class IIMicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single uJuly 5, 2012
D-1414-2012Class IIKleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Liter (33.8 fl oz.), b) 1.June 14, 2012
D-1415-2012Class IIKleenex Foam Hand Sanitizer, Alcohol Free in a) 1.5 fl oz. (45mL) , b) 8 fl oz. (236mL) , and c) 16 June 14, 2012
Z-2181-2012Class IIKimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Warming April 27, 2012
Z-2425-2012Class IIIULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA FabrDecember 31, 2010
Z-0451-2013Class IIKimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulatiSeptember 16, 2010
Z-2415-2012Class IIKimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are PerJune 22, 2010
Z-2416-2012Class IIKimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are PercutaneoJune 22, 2010
Z-2018-2012Class IIMicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made in HondurasSeptember 17, 2009
Z-2017-2012Class IIMicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras. ThSeptember 17, 2009

Recent 510(k) Clearances

K-NumberDeviceDate
K231435KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, OpioiAugust 28, 2023
K231021KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid FenJuly 21, 2023
K223749U by Kotex® Click® Unscented Menstrual TamponsJanuary 6, 2023
K200072KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the OpApril 10, 2020
K172118U by Kotex Click Unscented Menstrual TamponsOctober 11, 2017
K143164ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter SetDecember 2, 2014
K140539AERO BLUE PERFORMANCE SURGICAL GOWNJune 9, 2014
K122653MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIESJune 26, 2013
K120650POISE PERSONAL LUBRICANTJuly 11, 2012
K113333KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTSMay 11, 2012
K113036U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONSNovember 2, 2011