Z-0354-2020 Class II Terminated
FDA device recall Z-0354-2020 was initiated by Monarch Medical Technologies on October 1, 2019 and is designated Class II. Reason for recall: Product was distributed prior to approval or clearance from FDA. The recall status is terminated (terminated February 10, 2026). Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2019
- Initiation Date
- October 1, 2019
- Termination Date
- February 10, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
Reason for Recall
Product was distributed prior to approval or clearance from FDA.
Distribution Pattern
SC, IL IN, CA
Code Information
versions: v 1.7.1, 1.7.4, 1.7.5