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
FDA Recall Z-1897-2017 · Posted None
Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeFPA
Date Initiated2016-12-23
Date Terminated2017-11-09
Product Quantity57,750 units
Reason for Recall
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.
Firm Action
Becton Dickinson (BD) notified their sole customer Medtronic via e-mail on December 26, 2016. BD recommends that Medtronic notify their customers of the situation. For further questions, please call (201) 847-6800.
Root Cause
Device Design
Distribution Pattern
US Distribution to the state of : CA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.