Z-1376-2021 Class II Ongoing
FDA device recall Z-1376-2021 was initiated by ROi CPS LLC on March 4, 2021 and is designated Class II. Reason for recall: 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 l… The recall status is ongoing. Affected quantity: 16 kits.
Recall Details
- Product Type
- Devices
- Report Date
- April 14, 2021
- Initiation Date
- March 4, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 kits
Product Description
Regard, Item Number 830067009, custom cardiovascular procedure kit
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the state of Missouri.
Code Information
Lot number: 75818I; Expiration Date: 05/18/2021