Recall MonitorHealth Products
Prismaflex Control Units
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Gastroenterology and urology
Product: Prismaflex Control Units
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Prismaflex ST100 Sets | All lots. | 107636 |
| Oxiris Set Row | All lots. | 973003 |
| Prismaflex HF1000 Set | All lots. | PRISMAFLEX HF1000 |
| Prismaflex HF1000 Set | All lots. | 107140 |
| Prismaflex ST150 Set | All lots. | PRISMAFLEX ST150 SET |
| Prismaflex ST150 Set | All lots. | 107640 |
| Prismaflex TPE 2000 Set | All lots. | 107144 |
| Prismaflex TPE 2000 Set | All lots. | PRISMAFLEX TPE 2000 |
Issue
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.