Recall Z-0111-2018
Medtronic Inc. · initiated September 10, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)
Codes / lots: Lot Numbers: 6211649, 6207537
Reason for recall
Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
FDA-determined cause: Component design/selection
Action taken
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.
Details
- Recall number
- Z-0111-2018
- Initiated
- September 10, 2017
- Product code
- FPK – Tubing, Fluid Delivery
- Quantity
- 5,842 units
- Distribution
- Worldwide
- Recalling firm
- Medtronic Inc., Northridge, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0107-2018 Class II | Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T…Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. | 09/10/2017Open, Classified |
| Z-0108-2018 Class II | Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T…Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. | 09/10/2017Open, Classified |
| Z-0109-2018 Class II | Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876…Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. | 09/10/2017Open, Classified |
| Z-0110-2018 Class II | Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943…Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. | 09/10/2017Open, Classified |