Recall Z-2207-2014 ยท FLD Apparatus, Hemoperfusion, Sorbent
Gambro Renal Products, Incorporated
X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
| Date | Aug 13, 2014 (initiated Jul 18, 2014) |
| Status | Terminated |
| Reason | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. |
| Root cause | Device Design |
| Action | Gambro sent an Urgent Field Safety Notice dated July 18, 2014 to all end-users. A Customer Reply Form was attached to the notice for customers to complete and return. |
| Quantity | 401,451 |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.