BD FlowSmart Set MiniMed Pro-set Recalled for Bent Catheters
Becton Dickinson is recalling 57,750 units of BD FlowSmart Set MiniMed Pro-set in California due to reports of bent catheters causing high blood glucose.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (high blood glucose) due to a mechanical defect (bent catheter), but the source text does not report hospitalizations or serious injuries, fitting the criteria for a High severity score.
Plain-English summary
Becton Dickinson & Company is recalling 57,750 units of the BD FlowSmart Set MiniMed Pro-set, a prescription-only medical device distributed by Medtronic MiniMed Inc. The recall is limited to the state of California. The affected lots have expiration dates of June 30, 2019, and July 31, 2019.
The recall was initiated because patients reported high blood glucose levels while using the device. Additionally, patients noticed that the catheter of the infusion set was bent or kinked. The FDA has classified this as a Class II recall.
Consumers who have this product should stop using it and contact the distributor or manufacturer for further instructions. The specific lot codes involved are 6203871, 6203860, 6207535, 6211649, 6207537, and 6211650.
The recalled product
- 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
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Infusion Set
- Affected units
- 57,750
Distribution
Distributed in 1 state:
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