[Recalled] Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box — Gambro initiated a field action on the Prisma and Prismaflex sets due to breaka… | FDA 2014-07-18
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box |
|---|---|
| Brand / manufacturer | Gambro Renal Products, Incorporated |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2199-2014 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 18 July 2014 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Gambro Renal Products, Incorporated
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.