Coltene Whaledent Recalls Latex Dental Dams Labeled as Non-Latex
Coltene Whaledent Inc. is recalling latex dental dams that were incorrectly packaged in non-latex packaging, posing a risk to patients with latex allergies.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves allergen mislabeling (latex) on a common allergen, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Coltene Whaledent Inc. is recalling 32 boxes of latex dental dams, with 15 individual dams per box. The affected products are identified by Model/Catalog number 1884-10840, Lot number 103G2, and an expiration date of 10/2016. The company discovered the issue after receiving a complaint regarding the incorrect color of the dental dams. An internal investigation revealed that latex dental dams had been packaged in non-latex packaging.
The recall is limited to products distributed in Memphis, TN. The mislabeling creates a risk for patients with latex allergies who may be exposed to latex products they believe are latex-free. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Dental professionals and patients who have used these specific latex dental dams should check their records for the lot number 103G2 and expiration date of 10/2016. If the product matches these details, it should be returned to the distributor or the manufacturer. Patients with known latex allergies should consult their healthcare provider if they have used these products.
The recalled product
- Product
- Latex Dental Dams labeled as Non-Latex Dental Dams
- Manufacturer
- Coltene Whaledent Inc
- Category
- Medical Device — Dental Supplies
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model/Catalog number 1884-10840 Lot number 103G2 Exp Date 2016/10
Distribution
Distribution scope not specified by the agency.
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