Prismaflex Hemodialysis Unit, Prismaflex With Software Release 4.00, 5.00, 6.10, 7.10, 8.10 (2018-05-03)

PRISMAFLEX Hemodialysis Unit Recall Baxter is recalling PRISMAFLEX hemodialysis units with software versions 4.00, 5.00, 6.10, 7.10, or 8.10 across Canada. The recall affects the device's medical functions, though specific technical details are not provided in this notice. This is a Class I recall, the most serious classification, indicating a potential for serious injury or death.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2018-06-01

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/bd3f1c0b-10f4-4b91-94af-11f26ffe4ef5