FDAClass IIAugust 20, 2014

X-mars Set recall

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

Why was X-mars Set recalled?

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number MARS Treatment Kit Type 1116/1 X-MARS US, Batch Number 0000020229, Expiry Date 02/2017

Product
X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
Recalling firm
Gambro Renal Products, Incorporated
Quantity
401,451
Distribution
Worldwide Distribution.
Recall date
August 20, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls