Mölnlycke issued an urgent field safety notice to warn of a potential safety issue with its procedure tray containing latex material.
During an inspection, the company observed an error on the procedure tray labels. Information on the label states that the tray does not contain “natural rubber latex.” However, some components within the trays do contain latex, and the company determined that the label should not include that statement.
The hazards include a possible allergic reaction if the user is a latex-sensitive person. The risk is associated with both the user and patient, so the company urged customers to ensure the procedure trays aren’t used by anyone sensitive to latex.
The primary purpose of the procedure trays is to provide a sterile co-packing of components for different clinical interventions. according to the safety notice out of Germany.
Mölnlycke told users to identify the affected device(s), quarantine the device(s) and take note of the amendment while making the safety notice information available to all users.