Recall Z-0749-2019— Kimberly-Clark Corporation

Name: FDA recall Z-0749-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-11

Class II · Terminated

Class II FDA medical device recall by Kimberly-Clark Corporation, initiated 2018-12-11, terminated 2021-06-02. It names one FDA 510(k) clearance: K112635. Product: U by Kotex¿ Sleek¿, Regular Tampons, 34 Count. Reason: Potential for tampon to come apart upon removal..

Recalling firm: Kimberly-Clark Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-12-11
Terminated: 2021-06-02
Firm location: Neenah, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K112635 — U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONSKimberly-Clark Corp.·cleared 2011-10-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

U by Kotex¿ Sleek¿, Regular Tampons, 34 Count

Reason for recall

Potential for tampon to come apart upon removal.

Data sourced from openFDA. This site is unofficial and independent of the FDA.