Device product
REGARD Newborn Tray
Z-0253-2022
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 88463
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12
- Official record key
device-enforcement:Z-0253-2022
Official wording
Reason: 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.
Code information: Lot number: 86453F
Distribution pattern: US Nationwide in the states of FL, LA and MO.
Derived failure modes
-
Unknown
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.