Latex Dental Dams labeled as Non-Latex Dental Dams
FDA device recall Z-2151-2014 · posted 2014-08-06 · Terminated
Recall details
- Recalling firm
- Coltene Whaledent Inc
- 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.
- 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.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- EIE
- Quantity affected
- 32 boxes, 15 individual dams per box
- Distribution
- Distributed in Memphis, TN.
- Date initiated
- 2013-12-11
- Date posted
- 2014-08-06
- Date terminated
- 2016-08-26
- Location
- Cuyahoga Falls, OH
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