Health product recall

Staysafe Disinfection Cap

Last updated

Summary

Product
Staysafe Disinfection Cap
Issue
Medical devices - Labelling and packaging
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Staysafe Disinfection Cap All lots. 2845091

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology & Urology
Companies
Fresenius Medical Care Ag & Co. Kgaa
Else-Kroner-Strasse 1, Bad Homburg, Germany, 61352
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-74415