Prisma, Oxiris and various Prismaflex Sets (2014-06-27)Health ProductsJun 27th, 2014 @ 12:00 AM
Basic Details
Department: Health Canada
Issue: Medical Devices
Category: Medical Device
Hazard classification: Type II
Alert type: Medical Device Recall
Audience: General Public, Healthcare Professionals, Hospitals
Products
| Lot or serial number | Companies | Brand name | Model or catalog number |
|---|---|---|---|
| All lots |
| H) Oxiris Set | OXIRIS |
| All lots |
| F) Prismaflex Sets HF1000/HF 1400 | PRISMAFLEX HF1000 |
| All lots |
| G) Prismaflex Set HF20 | PRISMAFLEX HF20 SET |
| All lots |
| D) Prismaflex Extracorporeal Filter Circuits TPE 2000 | PRISMAFLEX TPE 2000 |
| All lots |
| E) Prismaflex Sets | PRISMAFLEX M100 SET |
| All lots |
| B) Prismaflex Haemodialysis Sets with Filter | PRISMAFLEX ST100 SET |
| All lots |
| C) Prismaflex Extracorporeal Filter Circuits TPE 1000 | PRISMAFLEX TPE 1000 |
| All lots |
| A) Prisma Set | PRISMA M100 PRE SET |
Introduction
Recalled Products
- Prisma Set
- Prismaflex Haemodialysis Sets with Filter
- Prismaflex Extracorporeal Filter Circuits TPE 1000
- Prismaflex Extracorporeal Filter Circuits TPE 2000
- Prismaflex Sets
- Prismaflex Sets HF1000/HF 1400
- Prismaflex Set HF20
- Oxiris Set
Reason
These conditions may occur when liquid is present on the male or female parts of the luer connector before connection (for example, use of disinfectant or drops of priming or dialysate solution) and the wet connector is screwed by using the body of the luer connectors for tightening instead of screwing the coupling nut. Under these circumstances, the fluid on the cone can act as a lubricant and might lead to an over-tightening of the connection. The resulting luer connection may be difficult to disconnect and the male luer lock may break when applying a high mechanical force.
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