FDA-Device2017-05-10Class II
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
Becton Dickinson & Company
Hazard
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.
Sold states
US Distribution to the state of : CA
Affected count
57,750 units
Manufactured in
1 Becton Dr, Franklin Lakes, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1897-2017Don't want to check this manually?
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