Medline Industries, LP recalls Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Numbe
Recalled Product
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
Hazard / Issue
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.
Issued by
FDA
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