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Recall Observatory FDA recall evidence

Device product

Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box

Z-2195-2014

July 18, 2014

Class II

Product summary

Firm
Gambro Renal Products, Incorporated
Event
Event 68788
Status
Terminated
Classification
Class II
Quantity
401,451
Official record key
device-enforcement:Z-2195-2014

Official wording

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

Code information: Prisma M 60 PRE set (new design). Product number 103658. Batch number 12K1205G to 14B1003. Expiry 11/2014 to 02/2016.

Distribution pattern: Worldwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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