Product Safety Recalls

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ROi CPS LLC Recall 93525

Description: Regard Dressing change kit, Item Number 800026006

ROi CPS LLC Recall 93525 Information

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberZ-0596-2024
Event ID93525
Event DescriptionRegard Dressing change kit, Item Number 800026006
Product TypeDevices
DistributionUS Nationwide distribution in the state of Louisiana.
Quantity1830 units
Recall ReasonROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
Device Classification20240110
Device Code InfoUDI/DI 10194717107873, Lot Numbers: 98283, 97591, 97405, 97081, 96961, 95508, 94769, 94435, 94270
Center Classification Date20240103
Recall Initiation Date20231120
Recalling FirmROi CPS LLC
Initial Notification E-Mail
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