T.G. Eakin Limited is recalling approximately 35,400 cartons of Eakin Cohesive small seals (Model Number 839002), which are used as ostomy barrier seals. This voluntary recall was initiated because some cartons may contain individually packaged seals that are incorrectly labeled as Model Number 839005. Each affected carton contains 20 individually packaged seals distributed in Kentucky. Consumers should contact their healthcare provider or the manufacturer to ensure they are using the correct medical device.
The use of an incorrectly labeled ostomy seal may lead to the application of a product with different specifications than intended, potentially causing improper fit or skin irritation. No specific injuries have been reported, but accurate labeling is critical for medical device safety and patient care.
Contact healthcare provider or manufacturer
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Sources: FDA iRES · Raw API Response
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