FDAClass IIAugust 20, 2014

Prismaflex M100. Product number 106697. Each set is recall

Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box

Why was Prismaflex M100. Product number 106697. Each set is 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?

Prismaflex M100. Product number 106697. Batch number 12A0401G to 14C2802G. Expiry 01/2014 to 03/2016

Product
Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box
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)
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