Z-1407-2022Class II

Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item...

Name: Z-1407-2022 Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item...
Creator: ROi CPS LLC
Published: 2022-06-03
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2022-06-03 / Terminated / root cause: packaging

FDA source

ROi CPS LLC began a recall of Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV on 2022-06-03. FDA classified it as Class II and gives the reason as "Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1407-2022
Classification: Class II
Status: Terminated
Initiated: 2022-06-03
Posted: 2022-07-19
Terminated: 2023-04-14
Recalling firm: ROi CPS LLC
Product: Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
Root cause tag: packaging
FDA root cause: Process change control
Action: The recalling firm initiated the recall via telephone on 6/3/2022 to the direct consignee of Item 830019017, explained the reason for recall, and instructed the product be quarantined. The recalling firm also contacted the end user who had received distribution from the direct consignee. The end user was informed of the error and was requested to remove the affected lot from their inventory. The recalling firm worked with the end user to have the kits returned to the direct consignee where they were placed in quarantine. Regarding the recall of Item #830099008 and Item #830014016, the direct consignees were notified on 6/6/2022 via telephone requesting the affected kits be placed on hold and moved to a quarantined area. A follow-up email was sent to the recall coordinator for the direct consignees (which was the same recall coordinator) on 6/16/2022 which contained a correction notice. The email explained the issue and said the recalling firm has already performed rework on the kits in the inventory at their location (the two direct consignee locations) so no additional actions were required except for the completion of the reply form to indicate receipt of the notice. The attached Medical Device Correction Notice was dated 6/16/2022 and explained the issue, the affected product, the health risk assessment, and the actions taken by the recalling firm, which included rework of the products that had been returned to the direct consignees. The enclosed replay form was to be completed acknowledging the consignee has read and understands the notice.
Quantity in commerce: 86 kits
Distribution: Distribution was made to MO. There was no foreign/military/government distribution.
Product codes and lots: (1) Item #830099008 - Lot #92534, exp. 11/13/2022, UDI #10194717114895; (2) Item #830019017 - Lot #92612, exp. 8/31/2023, UDI #10194717113249.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1407-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1407-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-19
Z-1408-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-19

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)