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U.S. Department of Health and Human Services

Class 2 Device Recall Ultimate Dams

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  Class 2 Device Recall Ultimate Dams see related information
Date Initiated by Firm December 11, 2013
Date Posted August 06, 2014
Recall Status1 Terminated 3 on August 26, 2016
Recall Number Z-2151-2014
Recall Event ID 67640
Product Classification Dam, rubber - Product Code EIE
Product Latex Dental Dams labeled as Non-Latex Dental Dams
Code Information Model/Catalog number 1884-10840 Lot number 103G2 Exp Date 2016/10 
Recalling Firm/
Manufacturer		 Coltene Whaledent Inc
235 Ascot Parkway
Cuyahoga Falls OH 44223
For Additional Information Contact Vincet Yee
330-916-8858
Manufacturer 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.
FDA Determined
Cause 2		 Packaging change control
Action The firm issued a press release, called the distributor and sent a certified letter. The firm obtained the distributor's distribution list and sent recall notifications to all of these consignees.The firm included envelopes and return/reply cards, via response form mailed, certified mailing with return receipt.
Quantity in Commerce 32 boxes, 15 individual dams per box
Distribution Distributed in Memphis, TN.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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