Regard Kit containing the Microtek decanter recallZ-2685-2024 · ROi CPS LLC · initiated Jun 17, 2024
Open, Classified
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
Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
FDA root cause category: Pending
What the company is doing
The distributor was notified of the recall via letter emailed on 06/17/2024. The distributor was instructed to review their inventory to determine if the item listed in the letter is in the inventory; complete and return a response form, notify any customers to whom the product was distributed, end users should immediately quarantine any affected kits at their facility and discontinue use, and report any adverse health consequences experienced with the product to FDA.
Recall details
- Recall number
- Z-2685-2024
- Status
- Open, Classified
- Initiated by the company
- Jun 17, 2024
- Posted by the FDA
- Aug 16, 2024
- Recalling firm
- ROi CPS LLC
- Quantity
- 78 Kits
- Product code
- KPE
- Distribution
- US Nationwide distribution in the state of MO.
Product description
Regard Kit containing the Microtek decanter
Code information (models, lots, serial numbers)
Item Number: 830099009; UDI: 10194717116677; Lot number's 99206 (Expiration Date: 2024-09-15) and 100633 (Expiration Date: 2024-09-15)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Regard™ CV01005IRoi 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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