Drug recall
Brand Name: GMAX Product Name: SYR 10ML Control syringe Model/Catalog Number: TS3210L-M Product Description…
FDA recall event 94520 · Class II · Jiangsu Shenli Medical Production Co., Ltd.
Key facts
| Event ID | 94520 |
|---|---|
| Recall numbers | Z-2042-2024, Z-2043-2024, Z-2044-2024, Z-2045-2024, Z-2046-2024, Z-2047-2024, Z-2048-2024, Z-2049-2024, Z-2050-2024, Z-2051-2024, Z-2052-2024, Z-2053-2024 and 75 more |
| Recalling firm | Jiangsu Shenli Medical Production Co., Ltd. |
| Product type | Devices |
| Products | Brand Name: GMAX Product Name: SYR 10ML Control syringe Model/Catalog Number: TS3210L-M Product Description: NON-Sterile syringes without needles for single use Component: No, Brand Name: GMAX Product Name: SYR 10ML/LL Blue syringe Model/Catalog Number: TS2210B-M Product Description: NON-Sterile syringes without needles for single use Component: No, Brand Name: GMAX Product Name: SYR 10ML/LL syringe Model/Catalog Number: TS2210L-M Product Description: NON-Sterile syringes without needles for single use Component: No, Brand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number: TS2210S-M Product Description: NON-Sterile syringes without needles for single use Component: No, Brand Name: GMAX Product Name: SYR 12ML/LL syringe Model/Catalog Number: TS2212L-M Product Description: NON-Sterile syringes without needles for single use Component: No and 82 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). |
| Initiation date | Apr 5, 2024 |
| Report date | May 29, 2024 |
| City | Changzhou |
| Country | China |
| FEI number | 3003902757 |
At a glance
- 10–99 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: