FDA-Device2014-02-19Class II
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.
Ecolab Inc
Hazard
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
Sold states
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.
Affected count
1800 individual units
Manufactured in
370 Wabasha St N, N/A, Saint Paul, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0943-2014Don't want to check this manually?
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