Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Health Canada has posted a medical device safety alert concerning Gambro Lundia AB AK 98, 115V BIO/ AK 98, 115V SELF-CARE and AK98 V2 115V BIO VERSION / AK 98 V2 115V BIO SELF CARE/ AK 98 V3 [Affected product: AK 98, AK 98 (SW 2), AK 98 (SW 3); Model or catalogue number: 115249, 115251, 955406, 955407, 955606] [HKMD Number: 160157].
According to the Health Canada, the manufacturer is communicating important safety information regarding the potential for AK 98 hemodialysis devices to generate excessive Ultrafiltration (UF) in certain situations where treatment-related alarms occur, or where there is an ultrafilter leak. Excessive UF may present hazards for sensitive patients, such as low-weight patients, for whom target UF values of zero or very low volumes are desired.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/ak-98-115v-bio-ak-98-115v-self-care-and-ak98-v2-115v-bio-version-ak-98-v2-115v-bio
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 27 Mar 2024