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cGMP deviations
Defective container: cracked/broken cartridges
Undeclared Soy
May be contaminated with Clostridium botulinum
Wheat and Soy missing allergens from the product Contains Statement.
Potential issue where the IntelliVue monitors did not alarm.
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.