Recalls / —
—#152719
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
- FDA product code
- FPA — Set, Administration, Intravascular
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K160651
- Affected lot / code info
- 6203871 30-Jun-19 6203860 30-Jun-19 6207535 30-Jun-19 6211649 31-Jul-19 6207537 30-Jun-19 6211650 31-Jul-19
Why it was recalled
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 (FDA determination)
Device Design
Action the firm took
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.
Recalling firm
- Firm
- Becton Dickinson & Company
- Address
- 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815
Distribution
- Distribution pattern
- US Distribution to the state of : CA
Timeline
- Recall initiated
- 2016-12-23
- Terminated
- 2017-11-09
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #152719. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.