RecallWatchUSA

Home / Recalls / Medical Devices

Ecolab Inc recalls MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 10

Recalled February 19, 2014 · FDA recall Z-0943-2014 · Ecolab

Hazard
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. · FDA Class II
Units
1800 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, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702.
Manufacturer(s)
Ecolab Inc

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

Ecolab Inc recalls MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 10 | RecallWatchUSA