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ROi CPS LLC Recall 87658

Description: Regard Dressing Change Tray

ROi CPS LLC Recall 87658 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1542-2021
Event ID87658
Event DescriptionRegard Dressing Change Tray
Product TypeDevices
DistributionUS Nationwide distribution in the state of Louisiana.
Quantity272 trays
Recall ReasonChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.
Device Classification20210519
Device Code InfoLot Numbers: 86983C, 87081C and 86356C.
Center Classification Date20210507
Recall Initiation Date20210326
Recalling FirmROi CPS LLC
Initial Notification E-Mail
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