Health Canada — Medical Devices · Canada · 2026-05-06 · Type II
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Reported risk: BD has received complaints, and confirmed through internal inspection that stains are present on the surface of the affected SILASTIC® catheters. The cause of the stains was determined to be an increased amount of a raw material used in the manufacturing process. This raw material may be harmful if present in increased amounts on the surface of the catheter.
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