Recall Z-1376-2021 ยท OEZ Cardiovascular Procedure Kit
ROi CPS LLC
Regard, Item Number 830067009, custom cardiovascular procedure kit
| Date | Mar 4, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | A Recall notification letter titled, "URGENT - MEDICAL DEVICE RECALL NOTICE" and the Ecolab-Microtek recall notification were sent to the one consignee on 03/04/2021 via email. The recalling firm requested that the consignee review their inventory and immediately quarantine the affected Regard custom procedure kit lot if identified. The consignee is to complete the attached reply form indicating inventory on hand. The notice instructed the consignee to ensure that the notice is issued to the end users whom the kits were further distributed to using their internal recall procedures. The end use |
| Quantity | 16 kits |
| Distribution | US Nationwide distribution in the state of Missouri. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.