Z-0250-2022 Class II Terminated
FDA device recall Z-0250-2022 was initiated by ROi CPS LLC on August 10, 2021 and is designated Class II. Reason for recall: Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products. The recall status is terminated (terminated June 16, 2023). Affected quantity: 126 trays.
Recall Details
- Product Type
- Devices
- Report Date
- November 24, 2021
- Initiation Date
- August 10, 2021
- Termination Date
- June 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 126 trays
Product Description
REGARD Basic Cataract tray
Reason for Recall
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Distribution Pattern
US Nationwide in the states of FL, LA and MO.
Code Information
Lots numbers: 88797G, 88392G, 87844G, 86422G and 83645F