Z-1376-2021Class II

Regard, Item Number 830067009, custom cardiovascular procedure kit

Name: Z-1376-2021 Regard, Item Number 830067009, custom cardiovascular procedure kit
Creator: ROi CPS LLC
Published: 2021-03-04
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2021-03-04 / Open, Classified / root cause: manufacturing process

FDA source

ROi CPS LLC began a recall of Regard, Item Number 830067009, custom cardiovascular procedure kit on 2021-03-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1376-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-03-04
Posted: 2021-04-08
Recalling firm: ROi CPS LLC
Product: Regard, Item Number 830067009, custom cardiovascular procedure kit
Product code: OEZ 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.
Root cause tag: manufacturing process
FDA 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 in commerce: 16 kits
Distribution: US Nationwide distribution in the state of Missouri.
Product codes and lots: Lot number: 75818I; Expiration Date: 05/18/2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1376-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1376-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-14	2021-04-08

Product code OEZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)