Recall Z-2604-2017
Medtronic Inc. · initiated May 8, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1551, MMT-1751, MMT-1552, MMT-1752.
Codes / lots: Serial Number for MMT-1511 NG1009242U NG1009243U NG1009245U NG1009247U NG1009248U NG1009249U NG1009250U NG1009254U NG1009256U NG1009257U NG1009258U NG1009259U NG1009261U NG1009265U NG1009266U NG1009267U NG1009269U NG1009271U NG1009272U NG1009274U NG1009275U NG1009277U NG1009278U NG1009279U NG1009280U NG1009281U NG1009286U NG1009287U NG1009288U NG1009289U NG1009295U NG1009297U NG1009299U NG1009303U NG1009304U NG1009306U NG1009309U NG1009313U Serial Number for MMT-1711 NG1070644H NG1070700H NG1070655H NG1070689H NG1070665H NG1071450H NG1071495H NG1071520H NG1071531H NG1071367H NG1071067H NG1071076H NG1071086H NG1071097H NG1071105H NG1071133H NG1071156H NG1071170H NG1071151H NG1072180H NG1072237H NG1071273H NG1071334H NG1071338H NG1071279H NG1069437H NG1075802H NG1076744H NG1076746H NG1076747H NG1076381H NG1076722H NG1076725H NG1076726H NG1076730H NG1076716H NG1076718H NG1076727H NG1076739H NG1076719H NG1075617H NG1075642H NG1075713H NG1075747H NG1075753H NG1075777H NG1075790H NG1075815H NG1075781H NG1076743H NG1078606H NG1078607H NG1078609H NG1078610H NG1078602H NG1078084H NG1077009H NG1077019H NG1077027H NG1077031H NG1077033H NG1077754H NG1077768H NG1077786H NG1077796H NG1077800H…
Reason for recall
Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive.
FDA-determined cause: Device Design
Action taken
On May 19, 2017, an Urgent Field Safety Notification letter will be sent to customers to inform them that Medtronic MiniMed is recalling MiniMed 600 series insulin pumps because they may be temporarily stuck, and the keypad becomes unresponsive. Customers are instructed how the key becomes temporarily unresponsive, how to notice if this happens, and what to do if this happens to their pumps. Customers with questions or concerns are instructed to find an FAQ and a copy of the letter at http://www.medtronicdiabetes.com/notice6. Customers can also reach the Medtronic 24-Hour HelpLine at1-888-204-7616.
Details
- Recall number
- Z-2604-2017
- Initiated
- May 8, 2017
- Terminated
- January 20, 2021
- Product code
- OZP – Automated Insulin Dosing Device System, Single Hormonal Control
- Quantity
- 117,239 pumps
- Distribution
- US and OUS Angola Aruba Australia/NZ Austria Bahamas Bahrain Bangladesh Belgium Bolivia Botswana Bulgaria Cayman Islands Colombia Costa Rica Croatia Cyprus Czech Republic Denmark Dominican Republic El Salvador Estonia Faroe Islands Finland France Germany Greece Guadeloupe Guatemala Hong Kong Hungary Iceland India Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea Kuwait Latvia Lebanon…
- Recalling firm
- Medtronic Inc., Northridge, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2602-2017 Class II | MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck… | 05/08/2017Terminated |
| Z-2603-2017 Class II | MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755.Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck… | 05/08/2017Terminated |
| Z-2605-2017 Class II | MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782, MMT-1760.Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck… | 05/08/2017Terminated |