FDAFDA · Food and drugs·Recall number Z-2151-2014
Latex Dental Dams labeled as Non-Latex Dental Dams
Published August 13, 2014 · Recall initiated: December 11, 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
Colt¿ne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Coltene Whaledent Inc
- Distributor
- Distributed in Memphis, TN.
- Lot
- Model/Catalog number 1884-10840 Lot number 103G2 Exp Date 2016/10
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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