Inglat-O-Ball

• • Ongoing Z-1631-2022 FDA Class II ·initiated 25 May 2022

  Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

• • Terminated Z-1152-2021 FDA Class II ·initiated 21 Jan 2021

  The affected Milex Gellhorn pessaries were incorrectly manufactured with a long stem (2.170 ), instead of a short stem (1.670 or 1.960 nominal height) as required. The length discrepancy does not meet the released print dimensions.

• • Terminated Z-2054-2017 FDA Class II ·initiated 10 Apr 2017

  The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product and the Instructions for Use (IFU) correctly states that the pessary is manufactured from latex rubber.

• • Terminated Z-0253-2016 FDA Class III ·initiated 14 Sep 2015

  The products have been identified to have incorrect size prints on the MILEX PESSARY KIT packaging. While the Pessary pouch is marked with correct size, an incorrect label on the packaging does not meet the required release specification.

• 2 recalls, same reason

  • Terminated Z-0208-2015 FDA Class III ·initiated 30 Sep 2014
  • Terminated Z-0207-2015 FDA Class III ·initiated 30 Sep 2014

  Incorrect expiration date printed on the MILEX PESSARY KIT packaging

• 9 recalls, same reason

  • Terminated Z-1011-2013 FDA Class III ·initiated 26 Feb 2013
  • Terminated Z-1004-2013 FDA Class III ·initiated 26 Feb 2013
  • Terminated Z-1007-2013 FDA Class III ·initiated 26 Feb 2013
  • Terminated Z-1009-2013 FDA Class III ·initiated 26 Feb 2013
  • Terminated Z-1005-2013 FDA Class III ·initiated 26 Feb 2013
  • Terminated Z-1010-2013 FDA Class III ·initiated 26 Feb 2013
  • Terminated Z-1006-2013 FDA Class III ·initiated 26 Feb 2013
  • Terminated Z-1012-2013 FDA Class III ·initiated 26 Feb 2013
  • Terminated Z-1008-2013 FDA Class III ·initiated 26 Feb 2013

  Pessary mislabeled outer package may not reflect the size of the product contained in the package

510(k) Number

K904774 ↗

FDA Product Code

HHW

Device Class

Class II

Regulation

21 CFR Part 884.3575

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Curette, Proposed Tis-U-Trap, Metal

  Class II

  FDA 510(k) K760264 Active Cleared 6 Oct 1976

• Inflat-O-Ball

  Class II

  FDA 510(k) K904026 Active Cleared 10 Oct 1990

• Milex Kegel Perineal Exerciser

  Class II

  FDA 510(k) K862410 Active Cleared 31 Jul 1986

• Kopans Hookwire Lesion Localization Needle

  Class I

  FDA 510(k) K900903 Active Cleared 3 May 1990

• Pipet Curet

  Class II

  FDA 510(k) K001545 Active Cleared 15 Jun 2000

• Endo C Brush

  Class II

  FDA 510(k) K882628 Active Cleared 25 Jul 1988

See all devices from Milex Products, Inc. →