Tenderneeds Fertility LLC Recall 88225
Description: Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046
Tenderneeds Fertility LLC Recall 88225 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2182-2021 |
| Event ID | 88225 |
| Event Description | Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046 |
| Product Type | Devices |
| Distribution | Worldwide distribution. |
| Quantity | Unknown |
| Recall Reason | Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021. |
| Device Classification | 20210811 |
| Device Code Info | All lots sold prior to December 9, 2019. |
| Center Classification Date | 20210802 |
| Recall Initiation Date | 20201223 |
| Recalling Firm | Tenderneeds Fertility LLC |
| Initial Notification | Other |
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