FDAFDA · Food and drugs·Recall number Z-0022-2017
Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain
Published October 12, 2016 · Recall initiated: May 27, 2016
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
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ivoclar Vivadent, Inc.
- Distributor
- US Nationwide Distribution in the states of: AK, AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI.
- Lot
- Lot No: U51512, exp date: Nov 10 2017; U44051, exp date: Oct 19 2017; U43988, exp date: Nov 2 2017; U43931, exp date: Nov 2 2017; and U39054 exp date: Sep 17 2017
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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