Z-1362-2021 Class II Ongoing
FDA device recall Z-1362-2021 was initiated by Tenderneeds Fertility LLC on December 23, 2020 and is designated Class II. Reason for recall: Device was distributed without a proper marketing authorization. The recall status is ongoing. Affected quantity: Unknown.
Recall Details
- Product Type
- Devices
- Report Date
- April 14, 2021
- Initiation Date
- December 23, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Unknown
Product Description
Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)
Reason for Recall
Device was distributed without a proper marketing authorization.
Distribution Pattern
World-wide distribution.
Code Information
All lots