FDA-Device2014-02-19Class II
Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96 , REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Reps, Inc., Tinley Park, Illinois
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
6,000 individual units
Manufactured in
370 Wabasha St N, N/A, Saint Paul, MN, United States
Products
Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96 , REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Reps, Inc., Tinley Park, Illinois
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0948-2014Don't want to check this manually?
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