FDAClass IIAugust 20, 2014

PrisMARS Kit recall

PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch

Why was PrisMARS Kit 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 1115/1 PrisMARS US, Batch 0000017412 - 0000019827, Expiry Date 06/2014 to 05/2016

Product
PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch
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