Kotex Security Tampons (Several Type)

• • Terminated Z-0393-2012 FDA Unclassified (pre-2012) ·initiated 3 Nov 2011

  A limited number of Kotex Natural Balance Security Unscented Tampons, regular absorbency, are being recalled after a raw material contaminated with a bacterium, Enterobacter sakazakii, was found when testing the plunger portion of the applicator.

510(k) Number

K896994 ↗

FDA Product Code

HEB

Device Class

Class II

Regulation

21 CFR Part 884.5470

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Kimberly-Clark Child's Facemask

  Class II

  FDA 510(k) K113340 Active Cleared 4 May 2012

• Kotex Profile Shaped Maxi Pad

  Class I

  FDA 510(k) K871210 Active Cleared 10 Apr 1987

• Kimberly-Clark Self-Seal Pouch for Low Temperature Sterilization

  Class II

  FDA 510(k) K973827 Active Cleared 11 Feb 1998

• Kotex Security Tube Tampons

  Class II

  FDA 510(k) K885194 Active Cleared 1 Mar 1989

• Spunguard Face Mask Open recall

  Class II

  FDA 510(k) K823078 Active Cleared 7 Jan 1983

• Kotex Super Maxi Pads

  Class II

  FDA 510(k) K890013 Active Cleared 25 Apr 1989

See all devices from Kimberly-Clark Corporation →