Ansell Recalls Gammex Surgical Gloves Due to Latex Contamination
Ansell Healthcare Products is recalling 15 cases of Gammex Non-Latex Surgical Gloves because they incorrectly contained natural rubber latex gloves.
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 the presence of a major allergen (natural rubber latex) in a product labeled as non-latex, which fits the rubric criterion for allergen mislabeling on common allergens.
Plain-English summary
Ansell Healthcare Products LLC is initiating a voluntary recall of 15 cases of Gammex Non-Latex Sensitive Surgical Gloves. The recall is being conducted because the packaged contents incorrectly included a natural rubber latex surgical glove.
The affected product is identified by Lot 1607018105. The recall involves 15 cartons of the gloves. The product was distributed in the United States to the states of Pennsylvania, Florida, New Jersey, Illinois, and Massachusetts.
Consumers and healthcare facilities should check their inventory for this specific lot number. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.
The recalled product
- Product
- Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium Manufactured for/ Fabrique' pour: Ansell Healthcare products LLC.
- Manufacturer
- Ansell Healthcare Products LLC
- Category
- Medical Device — Surgical Gloves
- Hazard
- Affected units
- 15
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)
- Lot 1607018105
Distribution
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