Regard, Item Number 830067009, custom cardiovascular procedure kit
Recall
- Recall Number
- Z-1376-2021
- Event Number
- 87472
- Firm
- ROi CPS LLC
- FEI Number
- 3014527682
- Product Code
- OEZ
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- March 4, 2021
- Address
- 3000 E Sawyer Rd, Republic, MO, 65738-2758
Description
Regard, Item Number 830067009, custom cardiovascular procedure kit
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.
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 user is instructed not to use the affected kits containing the recalled Ecolab-Microtek item. The firm provided contact information so that the affected kits can be returned.
US Nationwide distribution in the state of Missouri.
16 kits