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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 Damssee related information
Date Initiated by FirmDecember 11, 2013
Date PostedAugust 06, 2014
Recall Status1 Terminated 3 on August 26, 2016
Recall NumberZ-2151-2014
Recall Event ID 67640
Product Classification Dam, rubber - Product Code EIE
ProductLatex 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 ContactVincet Yee
330-916-8858
Manufacturer Reason
for Recall		Coltne/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
ActionThe 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 Commerce32 boxes, 15 individual dams per box
DistributionDistributed in Memphis, TN.
Total Product Life CycleTPLC 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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