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Recall Observatory FDA recall evidence

Device product

BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton, Dickinson and Company USA BD Medical-Diabetes Care Becton Dickinson France SAS

Z-1897-2017

December 23, 2016

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 76294
Status
Terminated
Classification
Class II
Quantity
57,750 units
Official record key
device-enforcement:Z-1897-2017

Official wording

Reason: Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the catheter of the infusion set was bent/kinked.

Code information: 6203871 30-Jun-19 6203860 30-Jun-19 6207535 30-Jun-19 6211649 31-Jul-19 6207537 30-Jun-19 6211650 31-Jul-19

Distribution pattern: US Distribution to the state of : CA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the catheter of the infusion set was bent/kinked.