PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch
FDA Recall Z-2206-2014 · Posted 2014-08-13
Recalling FirmGambro Renal Products, Incorporated
Recall StatusTerminated
Product CodeFLD
Date Initiated2014-07-18
Date Terminated2015-02-05
Product Quantity401,451
Reason for Recall
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.