FDA (Devices) recall action 98329
The FDA (Devices) publishes a recall like this one as 42 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 42 pages.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medline is recalling 15 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 82,597 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline Industries, LP is recalling certain Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the products.
Medline is recalling 291 units of three burn care convenience kits due to calibration issues with sterilization and packaging equipment that may affect sterility assurance.
Medline is recalling 3,561 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 30,958 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 4,525 C-section convenience kits worldwide due to calibration issues with sterilization and packaging equipment that could affect sterility assurance.
Medline is recalling 117,907 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 23,238 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 27,320 labor and delivery convenience kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.
Medline Industries is recalling cardiac surgical convenience kits due to sterilization equipment calibration issues that could affect device sterility assurance levels.
Medline is recalling 72 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 553 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 808 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 7,575 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 70,376,042 units of surgical gowns because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 9,720 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 1,070 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 14,927,765 units of surgical drapes because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 175 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline Industries, LP is recalling various Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the products.
Medline is recalling 684 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 193,157 units of surgical packs because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.
Medline is recalling 448 units of its BASIC NERVE BLOCK TRAY W/LINEN (Model PAIN0150C) due to calibration issues with sterilization and packaging equipment that could affect the sterility assurance level of the devices.
Medline is recalling 108 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.