Latex Dental Dams labeled as Non-Latex Dental Dams
FDA Recall #Z-2151-2014 — Class II — December 11, 2013
Product Description
Latex Dental Dams labeled as Non-Latex Dental Dams
Reason for Recall
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.
Recalling Firm
Coltene Whaledent Inc — Cuyahoga Falls, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
32 boxes, 15 individual dams per box
Distribution
Distributed in Memphis, TN.
Code Information
Model/Catalog number 1884-10840 Lot number 103G2 Exp Date 2016/10
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated