Recall Z-0111-2018 ยท FPK Tubing, Fluid Delivery
Medtronic Inc.
Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)
| Date | Sep 10, 2017 |
| Status | Open, Classified |
| Reason | Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. |
| Root cause | Component design/selection |
| Action | The firm initiated its recall on 09/11/2017 by issuing a public notice, following with letters and emails. The firm also employed the use of Facebook and Twitter as well as posting on its website. The recall notice directs the customer to visit https://checklots.medtronicdiabetes.com for information on the lot numbers. Persons with additional questions may call Medtronic at 1.888.204.7616. |
| Quantity | 5,842 units |
| Distribution | Worldwide |
| 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 |