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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:151614

133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating Luer, 1 Ext, Item No. B59006 Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein). Each set will be manufactured to a unique specifications using dimensions, components and configurations specified by the customer.

Official recall number

Z-0980-2017

Evidence summary

Product code
FMG
Recall status
Terminated
Event initiated
November 30, 2016
Root cause
Mixed-up of materials/components
Source snapshot
d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product
Z-0980-2017

Field note

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