U by Kotex¿ Sleek¿, Regular Tampons, 34 Count
FDA Recall #Z-0749-2019 — Class II — December 11, 2018
Product Description
U by Kotex¿ Sleek¿, Regular Tampons, 34 Count
Reason for Recall
Potential for tampon to come apart upon removal.
Recalling Firm
Kimberly-Clark Corporation — Neenah, WI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
68,852,076 units total
Distribution
Nationwide distribution AR, AZ, CA, CT, FL, HI, IA, ID, IL, KS, LA, MA, MD, MI, MN, MO, MS, NC, NH, NY, OH, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI. International distribution to Canada.
Code Information
Package UPC: 36000426649; Case UPC: 10036000426646; Lot Numbers: NN628101A, NN628101B, NN628201A, NN628201B, NN629401A, NN629401B, NN631201B, NN631301A, NN632113B, NN632213A, NN633813D, NN634113B, NN634213A, NN635113C, NN703113A, NN703113B, NN705613C, NN706313C, NN706313D, NN706413C, NN706413D, NN707713C, NN707713D, NN711313C, NN711313D, NN711413A, NN713013B, NN713113A, NN714313B, NN714413A, NN714413B, NN719313B, NN719413A, NN722013B, NN722113A, NN722113B, NN722213A, NN724713A, NN724713B, NN726713D, NN726813A, NN728213B, NN728313A, NN729613A, NN729613B, NN729713A, NN732513B, NN732613A, NN733913A, NN733913B, NN735213B, NN735313A, NN801413C, NN801413D, NN802813D, NN802913A, NN804213D, NN804313A, NN805813A, NN805813B, NN807513D, NN807613C, NN809913A, NN811213C, NN811213D, NN815413D, NN816813D, NN818113C, NN818113D, NN822413D, NN822513A, NN824613B, NN824713A, NN826713A.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.