Regard, T AND A - Rogers, sterilized convenience kits recallZ-0469-2022 · ROi CPS LLC · initiated Nov 30, 2021
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 lacks rubber latex warning label.
FDA root cause category: Error in labeling
What the company is doing
A customer notification email dated 11/30/2021 was sent with recall instructions as follows: 1. Check: Please review your inventory to determine if the manufacturer item numbers and lot numbers listed in the table are in your inventory. 2. Quarantine: If the affected kits are identified, please quarantine the product and do not further distribute. 3. Label Affected kits: Use the label template attached to this notice to label affected kits in your inventory prior to shipping to customers. The label includes the statement "This kit contains a URETHRAL CATHETER RED RUBBER 12FR that contains natural rubber latex which may cause allergic reactions." The label should be placed in a location on the outer wrapper of the kits that is visible to end users. 4. Reply: Please complete the attached reply form indicating any inventory on hand at your facility. If you do not have inventory, please return the form indicating "0" inventory on hand. 5. Notify: Please immediately notify any customers to who, you have distributed or forwarded kits affected by this medical device correction notice. You may include a copy of this notice and the attached label template with your customer notification. 6. End users: Notices sent to end users should include the label template and instruction to label affected kits in their inventory. The label should be placed in a location on the outer wrapper of the kits that is visible to users of the kits.
Recall details
- Recall number
- Z-0469-2022
- Status
- Terminated
- Initiated by the company
- Nov 30, 2021
- Recalling firm
- ROi CPS LLC
- Quantity
- 195 kits
- Product code
- OGR
- Distribution
- US Nationwide distribution in the state of MO.
Product description
Regard, T AND A - Rogers, sterilized convenience kits
Code information (models, lots, serial numbers)
1) Item Number 8800313004, Lot Number 89090D (UDI 10194717110804); Expiration 07/15/2023 2) Item Number 8800313005, Lot Number 89378 (UDI 10194717112730); Expiration 08/05/2023
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Regard™ ET00743DRoi Cps, LLC · Ear, Nose, And Throat Surgical Tray1 recall1 report
- Regard™ ET00743ERoi Cps, LLC · Ear, Nose, And Throat Surgical Tray1 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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