Z-3159-2024Class II

regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009

Name: Z-3159-2024 regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Creator: ROi CPS LLC
Published: 2024-07-24
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2024-07-24 / Open, Classified / root cause: manufacturing process

FDA source

ROi CPS LLC began a recall of regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009 on 2024-07-24. FDA classified it as Class II and gives the reason as "Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3159-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-24
Posted: 2024-09-17
Recalling firm: ROi CPS LLC
Product: regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Product code: OEQ Angiography/Angioplasty Kit
Reason for recall: Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 3387 kits
Distribution: US Nationwide distribution in the state of North Carolina.
Product codes and lots: GTIN 10194717114116, Lot Numbers: 93697, 94061, 94452, 94912, 95813, 96271, 96464, 96833, 97051, 97411, 97893, 98446, 98913, 99464, 99912, 100447, 100757, 101527, 96833RS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3159-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3159-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-17

Product code OEQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)