FDAFDA · Food and drugs·Recall number Z-0948-2014
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
Published February 19, 2014 · Recall initiated: July 2, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ecolab Inc
- Distributor
- 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.
- Lot
- Lot Numbers: D111571, D120421, D123471, D83111, DA90721, and DA90961
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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