FDA Medical Device Recalls (openFDA)
ROi CPS LLC: Regard, Item Number 830067009, custom cardiovascular procedure kit
- Recall number
- Z-1376-2021
- Recalling firm
- ROi CPS LLC
- Product
- Regard, Item Number 830067009, custom cardiovascular procedure kit
- Status
- Open, Classified
- Initiated
- 2021-03-04
- Posted
- not on file
- Terminated
- not on file
- 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 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.
- Quantity
- 16 kits
- Distribution
- US Nationwide distribution in the state of Missouri.
- Lot, serial or model codes
- Lot number: 75818I; Expiration Date: 05/18/2021
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OEZ
- Firm FEI
- 3014527682
- Firm city
- Republic
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28