Medline identified calibration issues linked to the equipment used to sterilize the recalled products, impacting the sterility assurance level. This creates the potential for a non-sterile device to be placed within the sterile field, or be used within a sterile procedure. This could lead to contamination and/or patient infection. These products are found within kits and customers are being asked to quarantine affected kit lot numbers and will be provided over-labels.
RecallTracker