Z-0518-2021 Class II Ongoing
FDA device recall Z-0518-2021 was initiated by Medtronic Inc. on April 30, 2020 and is designated Class II. Reason for recall: Missing solder battery connection, which could interrupt power of insulin pump. The recall status is ongoing. Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- December 9, 2020
- Initiation Date
- April 30, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx Only - Product Usage: indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
Reason for Recall
Missing solder battery connection, which could interrupt power of insulin pump.
Distribution Pattern
Worldwide distribution - U.S. Nationwide Distribution in the state of MD and the countries of Canada, Netherlands, Norway. ***Model 630G distributed in Canada and Model 670G distributed in US ***MODEL640G Distributed OUS ONLY*** OUS: Australia, Canada, Netherlands and Norway.
Code Information
All serial numbers expiration date- 3 years from date of manufacture: NG2095284H, NG2095319H