Dear Valued Customer,
Cardinal is initiating a Medical Device Correction Notice for specific production lots of Coviden™ ChemoPlus™ Poly-coated Chemo Gowns due to potential rips, holes, tears, incomplete and/or open seams, staining, foreign material, or debris on the gowns. The affected product is a component within the Coviden™ ChemoPlus™ and ChemoBloc™ Chemo Spill and Preparation/Administration kits. Please see the table in attachment 1 for a listing of the impacted products.
The contract manufacturer failed to maintain an effective Quality Management System required for the production of gowns. As a result, gowns produced by this contract manufacturer could have rips, holes, tears, incomplete and/or open seams, staining, foreign material, or debris. The affected products could provide insufficient barrier protection for the end user or the gown could become contaminated and then worn by the end user when compounding, administering, or handling hazardous drugs. These hazardous situations could result in potential harms including chemical exposure or unspecified infection.
Cardinal has not received any reports of patient or user harm or injury related to this issue.
Please click on the button below to read the full statement from Cardinal and the list of products recalled.