Prismaflex St100, St150, Tpe 2000, Hf1000 And Hf1400 Sets, Oxiris Set (2019-04-25)

Recall Summary Baxter is recalling PRISMAFLEX ST100, ST150, TPE 2000, HF1000 and HF1400 blood filtration sets and OXIRIS sets used in critical care settings across Canada due to a manufacturing issue with these medical devices. The recall affects healthcare facilities and hospitals that use these blood purification products. This is classified as a Class I recall, the most serious category.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-05-10

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/a5dbfc3b-9dfc-4636-b2b6-5e1cc95404fe