Official recall record

Staysafe Disinfection Cap

Health Canada — Medical Devices · 2023-10-13 · CanadaType I

Issuing authority: Health Canada — Medical Devices
Published: 2023-10-13
Country of alert: Canada
Alert level: Type I
Alert type: recall

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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