12 recalls and government notices19 naming Kimberly-Clark Worldwide, Inc.
Notices naming Kimberly-Clark Worldwide, Inc.12
Each notice covers the product described in it, not every product on this page.
2021-02-01FDA · Class IITerminated
Made or stored in conditions that were not clean enough.
What it covered, and the record
The notice says: Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled as Moisturizing Foam Hand Sanitizer
What it covered: Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, GA 30076-2199 Distributed in Canada by Kimberly-Clark Inc., Mississauga, Ontario L5B 3Y5 UPC 0 36000 91592 1
Product may contain a cannula with an active tip length of only 5mm rather than 10mm as indicated on the label.
What it covered, and the record
What it covered: Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10 The product is used to create lesions in nervous tissue when used with the Kimberly-Clark radiofrequency generator and probes.
The notice says: Kimberly-Clark Single Shot Epidural Pain Management Trays contain the BD 7 mL Epilor plastic Luer-Lok LOR Syringes under recall by Becton Dickinson (BD) because the product may stall or stick when traveling within the barrel of the syringe.
What it covered: Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs
Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.
What it covered, and the record
What it covered: KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider.
Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
The agency filed 2 records under this notice, one per affected product line.
What it covered, and the record
What it covered: MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Something may have got into the product that should not be there.
The agency filed 2 records under this notice, one per affected product line.
What it covered, and the record
The notice says: Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.
What it covered: Kleenex Foam Hand Sanitizer, Alcohol Free in a) 1.5 fl oz. (45mL) , b) 8 fl oz. (236mL) , and c) 16 fl oz (473mL) bottles, Distributed by Kimberly Clark, LLC, Roswell, GA 30076
The notice says: A defect of the "fuse holder" can lead to a Control Unit failure that may cause the device to lose its ability to warm and maintain set temperature and may also result in excessive heat with the fuse assembly that could lead to the generation of smoke.
What it covered: Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Warming System - Model 1000 Control Unit and Energy Transfer Pads is a thermal regulating system, indicated for monitoring and controlling patient temperature.
The impacted product was not intended for commercial distribution to end users.
What it covered, and the record
What it covered: ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.
What it covered, and the record
What it covered: Kimberly-Clark Patient Warming System - Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature.
May contain small pieces of something that should not be in food.
The agency filed 2 records under this notice, one per affected product line.
What it covered, and the record
The notice says: The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube.
What it covered: Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk.
Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.
The agency filed 2 records under this notice, one per affected product line.
What it covered, and the record
What it covered: MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.