FDA Device recall Z-3159-2024
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
- FDA Device
- Class II
- ongoing
- Published 2024-09-25
On 2024-09-25 the FDA classified a Class II recall of regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009 by Roi Cps, citing medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3159-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-24 |
| Published | 2024-09-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Roi Cps |
| Distribution | US |
Product
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Reason
Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
Identifiers
| code_info | GTIN 10194717114116, Lot Numbers: 93697, 94061, 94452, 94912, 95813, 96271, 96464, 96833, 97051, 97411, 97893, 98446,…GTIN 10194717114116, Lot Numbers: 93697, 94061, 94452, 94912, 95813, 96271, 96464, 96833, 97051, 97411, 97893, 98446, 98913, 99464, 99912, 100447, 100757, 101527, 96833RS |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Roi Cps
- regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator
FDA Device · Class I · 2025-02-12 · Roi Cps - Regard Kit containing the Microtek decanter
FDA Device · Class II · 2024-08-28 · Roi Cps - regard Operative LAP, Item Number 800943001
FDA Device · Class I · 2024-01-24 · Roi Cps - Regard Dressing change kit, Item Number 800026006
FDA Device · Class I · 2024-01-10 · Roi Cps - Regard CV PK, Item Numbers a) 880289014, b) 880289015
FDA Device · Class II · 2023-11-22 · Roi Cps
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3159-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.