FDAClass IIAugust 13, 2014

Latex Dental Dams labeled as Non-Latex Dental Dams recall

Latex Dental Dams labeled as Non-Latex Dental Dams

Why was Latex Dental Dams labeled as Non-Latex Dental Dams 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model/Catalog number 1884-10840 Lot number 103G2 Exp Date 2016/10

Product
Latex Dental Dams labeled as Non-Latex Dental Dams
Recalling firm
Coltene Whaledent Inc
Quantity
32 boxes, 15 individual dams per box
Distribution
Distributed in Memphis, TN.
Recall date
August 13, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls