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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:167902

EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.

Official recall number

Z-0363-2019

Evidence summary

Product code
KPE
Recall status
Terminated
Event initiated
September 12, 2018
Root cause
Process control
Source snapshot
d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product
Z-0363-2019

Field note

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