Recall Z-0254-2022
ROi CPS LLC · initiated August 10, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
REGARD Stereotactic Tray
Codes / lots: Lots numbers: 81985C, 80891C and 80379C
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
The correction was sent via e-mail on 08-10-2021 instructing the consignees to removed the Swabsticks (3's) and be discarded at time of use.
Details
- Recall number
- Z-0254-2022
- Initiated
- August 10, 2021
- Terminated
- June 16, 2023
- Product code
- OIP – Radiology-Diagnostic Kit
- Quantity
- 175 trays
- Distribution
- US Nationwide in the states of FL, LA and MO.
- Recalling firm
- ROi CPS LLC, Republic, MO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0250-2022 Class II | REGARD Basic Cataract trayPovidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a… | 08/10/2021Terminated |
| Z-0251-2022 Class II | REGARD Core Biopsy TrayPovidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a… | 08/10/2021Terminated |
| Z-0252-2022 Class II | REGARD Ear TrayPovidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a… | 08/10/2021Terminated |
| Z-0253-2022 Class II | REGARD Newborn TrayPovidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a… | 08/10/2021Terminated |
| Z-0255-2022 Class II | REGARD Ultrasound TrayPovidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a… | 08/10/2021Terminated |
| Z-0256-2022 Class II | REGARD Vitrectomy TrayPovidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a… | 08/10/2021Terminated |