Latex Dental Dams labeled as Non-Latex Dental Dams
This recall has been terminated (originally issued August 6, 2014).
- Company
- Coltene Whaledent Inc
- Recall Initiated
- December 11, 2013
- Posted
- August 6, 2014
- Terminated
- August 26, 2016
- Recall Number
- Z-2151-2014
- Quantity
- 32 boxes, 15 individual dams per box
- Firm Location
- Cuyahoga Falls, OH
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed in Memphis, TN.
Lot / Code Info
Model/Catalog number 1884-10840 Lot number 103G2 Exp Date 2016/10
Root Cause
Packaging change control
Action Taken
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.
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