Wrist and Thumb Orthosis Recalled for Undeclared Latex
North Coast Medical Inc is recalling the Gladiator Wrist & Thumb Orthosis because the thumb strap may contain latex that is not declared on the product label. People with latex allergies are at risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This recall involves allergen mislabeling of a common allergen (latex) on a medical device. No illnesses or injuries have been reported. The product poses a potential risk of harm to individuals with latex allergies where injury has not yet been documented, meeting the criteria for High severity.
Plain-English summary
North Coast Medical Inc is recalling the Gladiator Wrist & Thumb Orthosis (Part Numbers NC86650 through NC86657, all sizes and sides). All units without a manufacturing date on the label are affected by this recall.
The thumb strap of this orthosis may contain latex that is not declared in the product labeling. Because latex is a known allergen, individuals with latex allergies could experience an allergic reaction upon contact with the undeclared material in the thumb strap.
The affected devices were distributed in the United States (North Carolina, California, Wisconsin) and internationally (New Zealand and Australia). A total of 27 units were distributed.
Consumers who have purchased this product should stop using it immediately if they have a known latex allergy. Those with questions or who believe they may have been affected should contact North Coast Medical Inc for instructions on product return or replacement.
The recalled product
- Product
- Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654 (Large/Left), NC86655 (Large/Right), NC86656 (X-Large/Left), and NC86657 (X-Large/Right)
- Manufacturer
- North Coast Medical Inc
- Affected units
- 27
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)
- All Model Numbers without a manufacturing date on label
Distribution
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