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Lack of Processing Controls.
Pecans have the potential to be contaminated with Salmonella
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Due to out of the box wobble of the driver.
Surgical drape packs may have open seals, which may compromise the sterility of the product.
Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
Measles IgM Test Kit lacks premarket approval or clearance.
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
Potential contamination with Listeria monocytogenes.