FDAFDA · Food and drugs·Recall number Z-0037-2017
Zenostar MT Color Impulse orange, art. no. 681168. 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: U44402, expiration date: Oct 19 2017; V01767, expiration date: Jan 18 2018; U52968, expiration date: Jan 18 2018; U53010, expiration date: Nov 16 2017; and U38982, expiration date: Sep 17 2017
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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