FDAClass IIAugust 20, 2014

Prisma M100 PRE pump infusion set. Product number recall

Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box

Why was Prisma M100 PRE pump infusion set. Product number 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?

Prisma M100 PRE pump infusion set. Product number 107791. Batch number 12A2305 to 13D0902. Expiry 01/2014 to 04/2015

Product
Prisma M100 PRE pump infusion set. Product number 107791. 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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