CanadaPrismaflex sets used with Prismaflex control units—specifically Prismaflex ST100 Set (model 107636), Oxiris Set Row (973003), Prismaflex HF1000 Set (PRISMAFLEX HF1000 and 107140), Prismaflex ST150 Set (PRISMAFLEX ST150 SET and 107640), and Prismaflex TPE 2000 Set (107144 and PRISMAFLEX TPE 2000); all lots—are affected. They were recalled because the Prismaflex Set deaeration chamber can potentially become dislodged from the Prismaflex control unit; this issue does not affect PrisMax control units. Contact the manufacturer, Vantive Health GmbH, for additional information.
What's being recalled
Companies: Vantive Health Gmbh, Thurgauerstrasse 130, Glattpark (Opfikon), Switzerland, 8152.
How to identify it
Affected products: Prismaflex ST100 Sets; Lot or serial number: All lots.; Model or catalogue number: 107636
Affected products: Oxiris Set Row; Lot or serial number: All lots.; Model or catalogue number: 973003
Affected products: Prismaflex HF1000 Set; Lot or serial number: All lots.; Model or catalogue number: PRISMAFLEX HF1000
Affected products: Prismaflex HF1000 Set; Lot or serial number: All lots.; Model or catalogue number: 107140
Affected products: Prismaflex ST150 Set; Lot or serial number: All lots.; Model or catalogue number: PRISMAFLEX ST150 SET
Affected products: Prismaflex ST150 Set; Lot or serial number: All lots.; Model or catalogue number: 107640
Affected products: Prismaflex TPE 2000 Set; Lot or serial number: All lots.; Model or catalogue number: 107144
Affected products: Prismaflex TPE 2000 Set; Lot or serial number: All lots.; Model or catalogue number: PRISMAFLEX TPE 2000
The hazard
Vantive is issuing an urgent medical device correction to all Prismaflex control unit users due to the potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex control unit, as shown in figure 3 below. This issue does not affect PrisMax control units and may occur only when the Prismaflex sets are being used with the Prismaflex control unit, as the two machines have different deaeration chamber holder designs.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)