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Terminated

Latex Dental Dams labeled as Non-Latex Dental Dams

FDA Recall Z-2151-2014 · Posted 2014-08-06

Recalling FirmColtene Whaledent Inc
Recall StatusTerminated
Product CodeEIE
Date Initiated2013-12-11
Date Terminated2016-08-26
Product Quantity32 boxes, 15 individual dams per box

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.

Firm 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.

Root Cause

Packaging change control

Distribution Pattern

Distributed in Memphis, TN.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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