Nonsterile convenience kits recallZ-1407-2022 · ROi CPS LLC · initiated Jun 3, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ROi CPS LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
FDA root cause category: Process change control
What the company is doing
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.
Recall details
- Recall number
- Z-1407-2022
- Status
- Terminated
- Initiated by the company
- Jun 3, 2022
- Posted by the FDA
- Jul 19, 2022
- Recalling firm
- ROi CPS LLC
- Quantity
- 86 kits
- Product code
- OEZ
- Distribution
- Distribution was made to MO. There was no foreign/military/government distribution.
Product description
Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
Code information (models, lots, serial numbers)
(1) Item #830099008 - Lot #92534, exp. 11/13/2022, UDI #10194717114895; (2) Item #830019017 - Lot #92612, exp. 8/31/2023, UDI #10194717113249.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Regard™ CV01005HRoi Cps, LLC · Cardiovascular Procedure Kit2 recalls1 report
- Regard™ CV00214QRoi Cps, LLC · Cardiovascular Procedure Kit1 recall1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 90492).
- Z-1408-2022 · TerminatedNonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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