Z-0524-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 9, 2020
- Initiation Date
- October 12, 2020
- Termination Date
- May 13, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 220 kits
Product Description
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
Reason for Recall
Labeling error, incorrect expiration date.
Distribution Pattern
US Nationwide distribution in the states of MO and OK.
Code Information
Lot Numbers: 78483C, 79932C, 81043C, 82586C, 83090C.