regard Clinical Packaging Solutions — Class II medical device recall Z-3159-2024
Ongoing recall by ROi CPS LLC, reported 2024-09-25, distributed nationwide. Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Producti
| Recall number | Z-3159-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi CPS LLC, Republic, MO, United States |
| Recall initiated | 2024-07-24 |
| Classified | 2024-09-17 |
| Reported by FDA | 2024-09-25 |
| Distributed | Nationwide (US) |
| Quantity | 3,387 kits |
| UPC / GTIN / UDI-DI | 10194717114116 |
| Lot numbers | 100447, 100757, 101527, 93697, 94061, 94452, 94912, 95813, 96271, 96464, 96833, 96833RS, 97051, 97411, 97893, 98446, 98913, 99464, 99912 |
| Model numbers | 800223009 |
Product
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Reason for recall
Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3159-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.