Regard brand CABG Pack A and B - Spartanburg recallZ-1051-2022 · ROi CPS LLC · initiated Mar 21, 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
Kits were packed into shipping boxes incorrectly.
FDA root cause category: Under Investigation by firm
What the company is doing
An email notification of the recall was sent to the single impacted consignee (a distributor) on 03/29/2022. The consignee was instructed to complete the following: 1) Check: Please review inventory and determine if affected product is inventory. 2) Quarantine: Kits containing a special inspection label are approved to be used. Only quarantine and report kits that do not have this special label. If unlabeled kits are identified, immediately quarantine and do not further distribute. 3) Reply: Complete reply form indicating the number of kits in quarantine. Send the reply to [email protected] so a return can be arranged. 4) Notify: Notify immediately any customers to whom you have distributed or forwarded product affected by this recall. Include the recall letter to supplement your notification.
Recall details
- Recall number
- Z-1051-2022
- Status
- Terminated
- Initiated by the company
- Mar 21, 2022
- Recalling firm
- ROi CPS LLC
- Quantity
- 85 kits
- Product code
- OEZ
- Distribution
- Recall impacted one domestic consignee in NC
Product description
Regard brand CABG Pack A and B - Spartanburg
Code information (models, lots, serial numbers)
Item Number: 800208017, Lot 91156 UDI: (01)10194717112495(17)230101(10)91156
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Regard™ CV00361QRoi Cps, LLC · Cardiovascular Procedure Kit1 recall0 reports
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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