Z-1786-2019 Class II Ongoing
FDA device recall Z-1786-2019 was initiated by Monarch Medical Technologies on May 3, 2019 and is designated Class II. Reason for recall: Insulin dosing calculations were erroneously high. The recall status is ongoing. Affected quantity: 83 downloads.
Recall Details
- Product Type
- Devices
- Report Date
- June 26, 2019
- Initiation Date
- May 3, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 83 downloads
Product Description
Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
Reason for Recall
Insulin dosing calculations were erroneously high.
Distribution Pattern
Nationwide and Dubai
Code Information
Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10