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Recall Observatory FDA recall evidence

Device product

U by Kotex¿ Sleek¿, Regular/Super Tampons, 34 Count Multipack

Z-0750-2019

December 11, 2018

Class II

Product summary

Firm
Kimberly-Clark Corporation
Event
Event 81759
Status
Terminated
Classification
Class II
Quantity
68,852,076 units total
Official record key
device-enforcement:Z-0750-2019

Official wording

Reason: Potential for tampon to come apart upon removal.

Code information: Package UPC: 36000426663; Case UPC: 10036000426660; Lot Numbers: NN629401B, NN629501A, NN631301B, NN631401A, NN631401B, NN632213A, NN632213B, NN703113B, NN703213A, NN705513D, NN706513A, NN706513B, NN706613A, NN706613B, NN708713A, NN708713B, NN711413A, NN711413B, NN713113A, NN713113B, NN713213C, NN713213D, NN714513B, NN714613C, NN716613A, NN719413B, NN719513C, NN720613B, NN720713A, NN724713B, NN724813A, NN726813A, NN726813B, NN726913A, NN728313A, NN728313B, NN729713A, NN729713B, NN730913C, NN730913D, NN732613B, NN733813B, NN733913A, NN735313A, NN735313B, NN801413D, NN801513A, NN802913A, NN804313A, NN804313B, NN805713B, NN805813A, NN809913B, NN811213D, NN812613D, NN812713A, NN814013C, NN814013D, NN815513A, NN816813D, NN816913A, NN819613C, NN819613D, NN822513A, NN822513B, NN826613C, NN826613D, NN826713A.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for tampon to come apart upon removal.