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ROi CPS LLC Recall 88463

Description: REGARD Newborn Tray

ROi CPS LLC Recall 88463 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0253-2022
Event ID88463
Event DescriptionREGARD Newborn Tray
Product TypeDevices
DistributionUS Nationwide in the states of FL, LA and MO.
Recall ReasonPovidone-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.
Device Classification20211124
Device Code InfoLot number: 86453F
Center Classification Date20211118
Recall Initiation Date20210810
Recalling FirmROi CPS LLC
Initial Notification E-Mail
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