BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic… — Class II medical device recall Z-1897-2017
Terminated recall by Becton Dickinson & Company, reported 2017-05-10, distributed in CA. Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the ca
| Recall number | Z-1897-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Company, Franklin Lakes, NJ, United States |
| Recall initiated | 2016-12-23 |
| Classified | 2017-05-01 |
| Reported by FDA | 2017-05-10 |
| Terminated | 2017-11-09 |
| Distributed | CA |
| Quantity | 57,750 units |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1897-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.