Recall Z-1897-2017 ยท FPA Set, Administration, Intravascular
Becton Dickinson & Company
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
| Date | Dec 23, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| 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. |
| Quantity | 57,750 units |
| Distribution | US Distribution to the state of : CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160651 | BD FlowSmart Set, MiniMed Pro-Set Becton, Dickinson and Company, Apr 7, 2016 |