Reported Aug 13, 2014 · Terminated

Latex Dental Dams labeled as Non-Latex Dental Dams

Coltene Whaledent Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Coltene Whaledent Inc · 235 Ascot Parkway · Cuyahoga Falls, OH · 44223

Is this the product you have?

  • Latex Dental Dams labeled as Non-Latex Dental Dams
Lot codes and dates
  • Model/Catalog number 1884-10840 Lot number 103G2 Exp Date 2016/10
Amount recalled
32 boxes, 15 individual dams per box

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 26, 2016 · Data as of Sep 19, 4:52 PM UTC

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