ROi CPS LLC Recall 87472
Description: Regard, Item Number 830067009, custom cardiovascular procedure kit
ROi CPS LLC Recall 87472 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1376-2021 |
| Event ID | 87472 |
| Event Description | Regard, Item Number 830067009, custom cardiovascular procedure kit |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of Missouri. |
| Quantity | 16 kits |
| Recall Reason | ROi 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 Classification | 20210414 |
| Device Code Info | Lot number: 75818I; Expiration Date: 05/18/2021 |
| Center Classification Date | 20210408 |
| Recall Initiation Date | 20210304 |
| Recalling Firm | ROi CPS LLC |
| Initial Notification | |
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