regard Clinical Packaging Solutions, HT00376I - SPECIAL… recallZ-3159-2024 · ROi CPS LLC · initiated Jul 24, 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
Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
FDA root cause category: Process control
What the company is doing
ROi CPS, LLC issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its sole consignee on 07/24/2024 via Fed Ex. The notice explained the issue, potential risk, and requested the following actions be taken: 1. CHECK: Please review your inventory to determine if the item number and lots listed in the above table is in your inventory. 2. QUARANTINE: If the affected kits are identified, please immediately quarantine the kits and do not further use or distribute them. 3. REPLY: Please complete and return the attached reply form to indicate the quantity of each lot of affected ROi CPS, LLC kits are in your inventory. a. Please email the completed reply form to [email protected] b. Once received, ROi will issue labels to add to each affected kit in your inventory. c. Labels are to be placed in a location that is visible to the end users of the kits. d. Once labeled, the kits can be released back into inventory. 4. NOTIFY: Please notify any customers to whom you have distributed or forwarded the product affected by this urgent medical device correction. 5. END USERS: End users should immediately quarantine affected ROI CPS, LLC kits in their inventory that do not have the above label applied to the kit. Additional labels for customer inventory will be supplied upon request. Please email [email protected] to request additional labels.
Recall details
- Recall number
- Z-3159-2024
- Status
- Open, Classified
- Initiated by the company
- Jul 24, 2024
- Posted by the FDA
- Sep 17, 2024
- Recalling firm
- ROi CPS LLC
- Quantity
- 3387 kits
- Product code
- OEQ
- Distribution
- US Nationwide distribution in the state of North Carolina.
Product description
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Code information (models, lots, serial numbers)
GTIN 10194717114116, Lot Numbers: 93697, 94061, 94452, 94912, 95813, 96271, 96464, 96833, 97051, 97411, 97893, 98446, 98913, 99464, 99912, 100447, 100757, 101527, 96833RS
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Regard™ HT00376IRoi Cps, LLC · Angiography/Angioplasty 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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