ROi CPS LLC Regard, Item Number 830067009, custom cardiovascular procedure kit Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Regard, Item Number 830067009, custom cardiovascular procedure kit
Brand
ROi CPS LLC
Lot Codes / Batch Numbers
Lot number: 75818I, Expiration Date: 05/18/2021
Products Sold
Lot number: 75818I; Expiration Date: 05/18/2021
ROi CPS LLC is recalling Regard, Item Number 830067009, custom cardiovascular procedure kit due to ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer proced. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026