Z-0524-2021 Class II Terminated
FDA device recall Z-0524-2021 was initiated by ROi CPS LLC on October 12, 2020 and is designated Class II. Reason for recall: Labeling error, incorrect expiration date. The recall status is terminated (terminated May 13, 2021). Affected quantity: 220 kits.
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.