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Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries conducted its own investigation and concluded that the Pre-filled Water Syringe had been improperly used outside of the intended purpose.
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.