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ROi CPS LLC Recall 87472

Description: Regard, Item Number 830067009, custom cardiovascular procedure kit

ROi CPS LLC Recall 87472 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1376-2021
Event ID87472
Event DescriptionRegard, Item Number 830067009, custom cardiovascular procedure kit
Product TypeDevices
DistributionUS Nationwide distribution in the state of Missouri.
Quantity16 kits
Recall ReasonROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have slits in the product that may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment.
Device Classification20210414
Device Code InfoLot number: 75818I; Expiration Date: 05/18/2021
Center Classification Date20210408
Recall Initiation Date20210304
Recalling FirmROi CPS LLC
Initial Notification E-Mail
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