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Terminated

X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541

FDA Recall Z-2207-2014 · 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.

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