Ecolab Inc recalls MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU

Recalled February 19, 2014 · FDA recall Z-0945-2014 · Ecolab

Hazard

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

Units

12,546 individual units

Sold at

Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, Malta, Norway, Poland, Portugal, and Canada.

Description

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

Product

MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

Manufacturer(s)

Ecolab Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →