Kimberly-Clark announces voluntary recall of U by Kotex Sleek Tampons, Regular Absorbency, throughout the US and Canada.
Kimberly-Clark announced a voluntary product recall of its U by Kotex Sleek Tampons, Regular Absorbency, sold throughout the US and Canada for a quality-related defect that could impact the performance of the product.
The recall is limited to specific lots of U by Kotex Sleek Tampons, Regular Absorbency, that were manufactured between 7 October 2016 and 16 October 2018, and distributed between 17 October 2016 and 23 October 2018.
Consumers can identify this product by looking for specific lot numbers found on the bottom of the package. A full list of recalled lot numbers is available on the U by Kotex website. Retailers have been alerted to remove the recalled lot numbers from shelves and post a notification in their stores.
No other U by Kotex-branded products are subject to this recall.
Kimberly-Clark has received reports from consumers of the U by Kotex Sleek Tampons, Regular Absorbency, unravelling and/or coming apart upon removal, and in some cases causing users to seek medical attention to remove tampon pieces left in the body. There have also been a small number of reports of infections, vaginal irritation, localised vaginal injury, and other symptoms.
Any consumer with the impacted U by Kotex Sleek Tampons, Regular Absorbency, in their possession should stop using the product immediately and promptly contact Kimberly-Clark's Consumer Service team at 1-888-255-3499.
Consumers who experience vaginal injury (pain, bleeding, or discomfort), vaginal irritation (itching or swelling), urogenital infections (bladder and/or vaginal bacterial and/or yeast infections), or other symptoms such as hot flashes, abdominal pain, nausea, or vomiting following use of the impacted product should seek immediate medical attention.
US health care professionals and consumers may report adverse reactions or quality problems they may experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by facsimile to 1-800-FDA-0178.
Canadian health care professionals and consumers may report device-related incidents directly to Health Canada by completing a Health Product Complaint Form online.
