At the end of August 2022, Fresenius complaint handling unit (Germany) registered a complaint from New Zealand that an infant (no day fill) developed iodine induced hypothyroidism following use of stay safe disinfection cap. Further investigations revealed that the harm of hypothyroidism was not considered in master harms list and was not part of risk analysis for stay safe disinfection cap. Thus, no warning to the user was given. Even though the risk of hypothyroidism and hypersensitivity is known to medical practitioner, related warnings are not provided in the labeling. Recall start date: September 28, 2023
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