Microtek Probe Drape

• • Terminated Z-0753-2017 FDA Class III ·initiated 30 Nov 2016

  The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the incorrect expiration date (2015-10-01) on the label while the individual pouch labels and outer shipper have the correct expiration date (2018-10-01). The manufacturing date was inadvertently used as the expiration date on the inner carton box labels.

• • Terminated Z-0974-2014 FDA Class II ·initiated 12 Jul 2013

  No endotoxin (LAL) testing to proper level.

• 6 recalls, same reason

  • Terminated Z-0947-2014 FDA Class II ·initiated 2 Jul 2013
  • Terminated Z-0946-2014 FDA Class II ·initiated 2 Jul 2013
  • Terminated Z-0945-2014 FDA Class II ·initiated 2 Jul 2013
  • Terminated Z-0944-2014 FDA Class II ·initiated 2 Jul 2013
  • Terminated Z-0948-2014 FDA Class II ·initiated 2 Jul 2013
  • Terminated Z-0943-2014 FDA Class II ·initiated 2 Jul 2013

  Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.

510(k) Number

K882724 ↗

FDA Product Code

KKX

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Microtek's Surgical Lamp Handle & Cover

  Class II

  FDA 510(k) K901154 Active Cleared 20 Mar 1990

• Microtek Medical's Sound Stiks

  Class II

  FDA 510(k) K913276 Active Cleared 21 Oct 1991

• Disposable Arachnoid Knife

  Class I

  FDA 510(k) K882422 Active Cleared 6 Sep 1988

• 321Q Minimum Energy Tinnitus Suppressor

  Class II

  FDA 510(k) K922572 Active Cleared 2 Nov 1992

• Microtek Reuter-Style Bi-Valve Intranasal Splint

  Class I

  FDA 510(k) K895502 Active Cleared 8 Dec 1989

• Microtek-Heritages Silicone Bulb Evacuation System

  Class I

  FDA 510(k) K910167 Active Cleared 15 Apr 1991

See all devices from Microbio-Medics, Inc. →