regard Item Number: 800774001, CV00979A - CV Minor Kit… recallZ-1295-2022 · ROi CPS LLC · initiated May 20, 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
A nonsterile component was packaged in a sterile convenience kit.
FDA root cause category: Process change control
What the company is doing
The recalling firm called the consignee on 5/20/2022 to discuss the recall, including quarantine of affected product, customer fulfilment/available inventory, end user facility notification, recall timelines, and establishing a plan for relabeling by the recalling firm personnel at the distribution center. The recalling firm issued an email to the consignee on 5/20/2022 with an attached recall notice that was previously discussed with the consignee. The email requested the consignee to quarantine the kits and immediately notify the end user facilities who have been shipped the affected kits. In the email, the recalling firm reported they would be sending someone to the direct account and to the end user facilities to complete the correction of the affected kits. The attached letter dated 5/20/22 informed the customer of the reason for recall, health risk assessment, and the actions to be taken by customers. The letter contained a picture of the non-sterile Ultrasound Gel that is to be discarded from the kits. A Recall Reply Form was enclosed to indicate the quantity of product in the customer's possession. The customer was also supposed to indicate that they have read and understand the notice and it has been forwarded to all customers who have been shipped the affected product.
Recall details
- Recall number
- Z-1295-2022
- Status
- Terminated
- Initiated by the company
- May 20, 2022
- Posted by the FDA
- Jun 28, 2022
- Recalling firm
- ROi CPS LLC
- Quantity
- 180 kits
- Product code
- OEZ
- Distribution
- US Nationwide distribution in the state of FL.
Product description
regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
Code information (models, lots, serial numbers)
Lot #91423, Exp. 02/08/2024, UDI (01)10194717101949(17)240208(10)91423.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Regard™ CV00979ARoi Cps, LLC · Cardiovascular Procedure Kit1 recall1 report
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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