Prisma M 60 PRE set recall
Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box
Why was Prisma M 60 PRE 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?
Prisma M 60 PRE set (new design). Product number 103658. Batch number 12K1205G to 14B1003. Expiry 11/2014 to 02/2016.
- Product
- Prisma M 60 PRE set (new design). Product number 103658. 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)