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Recall Observatory FDA recall evidence

Device product

Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box

Z-2196-2014

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-2196-2014

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 M60 POSTDILUTION set. Product number 104183. Batch number 13C2103. Expiry 03/2015.

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.