Kimberly-Clark Announces Voluntary Recall of U by Kotex(R) Sleek(R) Tampons, Regular Absorbency,Throughout U.S. and Canada

Source: FDA Drug Recalls
Wed Dec 12, 2018 10:38AM

Kimberly-Clark announced a voluntary product recall of its U by Kotex® Sleek® Tampons, Regular Absorbency, sold throughout the United States and Canada for a quality-related defect that could impact the performance of this product.

The recall is limited to specific lots of U by Kotex® Sleek® Tampons, Regular Absorbency, that were manufactured between October 7, 2016 and October 16, 2018 and distributed between October 17, 2016 and October 23, 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, unraveling 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 also have been a small number of reports of infections, vaginal irritation, localized 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 between 7:30 a.m. – 7:00 p.m. Central Time, Monday through Friday, for information regarding this recall. 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.

U.S. 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-FDA0178.

Canadian health care professionals and consumers may report device-related incidents directly to Health Canada by completing a Health Product Complaint Form online.

U by Kotex Sleek Tampons, Regular Absorbency
Impacted Lot Code Listing

18 Count Package34 Count Package34 Count Multipack  (contains 17 U by Kotex  Sleek Tampons, Regular 

Absorbency)

3 Count 
Package
NN628201BNN728713CNN628101ANN724713ANN629401BNN728313BXM700604X
NN628301ANN728713DNN628101BNN724713BNN629501ANN729713AXM700904X
NN628301BNN729813ANN628201ANN726713DNN631301BNN729713BXM702304X
NN629101ANN731113ANN628201BNN726813ANN631401ANN730913CXM702404X
NN629101BNN732513BNN629401ANN728213BNN631401BNN730913DXM702504X
NN629201ANN733713DNN629401BNN728313ANN632213ANN732613B 
NN630201ANN733813ANN631201BNN729613ANN632213BNN733813B 
NN630201BNN800413BNN631301ANN729613BNN703113BNN733913A 
NN630301ANN800513CNN632101BNN729713ANN703213ANN735313A 
NN632713ANN802913BNN632113BNN732513BNN705513DNN735313B 
NN632713BNN803013ANN632213ANN732613ANN706513ANN801413D 
NN634713BNN804413ANN632213BNN733913ANN706513BNN801513A 
NN634813ANN804413BNN633813DNN733913BNN706613ANN802913A 
NN635713ANN807613DNN634113BNN735213BNN706613BNN803013B 
NN635713BNN807713CNN634213ANN735313ANN708713ANN804313A 
NN701813ANN808413CNN635013BNN801413CNN708713BNN804313B 
NN701813BNN808413DNN635113CNN801413DNN711413ANN805713B 
NN701913ANN812013ANN703113ANN802813DNN711413BNN805813A 
NN703213BNN812013BNN703113BNN802913ANN713113ANN809913B 
NN705713CNN812713BNN705613CNN804213DNN713113BNN811213D 
NN705713DNN812813ANN706313CNN804313ANN713213CNN812613D 
NN705813ANN814013DNN706313DNN805813ANN713213DNN812713A 
NN707613DNN814113ANN706413CNN805813BNN714513BNN814013C 
NN707713CNN814113BNN706413DNN807513DNN714613CNN814013D 
NN711513ANN815513ANN707713CNN807613CNN716613ANN815413D 
NN711513BNN815513BNN707713DNN809913ANN719413BNN815513A 
NN715213BNN819613DNN711313CNN811213CNN719513CNN816813D 
NN715313CNN819713ANN711313DNN811213DNN720613BNN816913A 
NN715313DNN821313ANN711413ANN815413CNN720713ANN819613C 
NN716713CNN822613BNN713013BNN815413DNN724713BNN819613D 
NN716713DNN822713ANN713113ANN815513DNN724813ANN822513A 
NN718313CNN824513DNN714313BNN816813DNN726813ANN822513B 
NN720713BNN824613ANN714413ANN818113CNN726813BNN826613C 
NN723413BNN824613BNN714413BNN818113DNN726913ANN826613D 
NN723513ANN826513DNN719313BNN822413DNN728313ANN826713A 
NN724913BNN826613CNN719413ANN822513A   
NN725013ANN827813DNN722013BNN824613B   
NN726913ANN827913CNN722113ANN824713A   
NN726913B NN722113BNN826713A   
  NN722213ANN826713B   

SOURCE Kimberly-Clark Corporation

Related Links http://www.kimberly-clark.com

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