Jiangsu Shenli Medical Production Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 87
- 510(k) Clearances
- 3
- Inspections
- 3
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2100-2024 | Class II | Brand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe Model/Catalog Number: | April 5, 2024 |
| Z-2114-2024 | Class II | Brand Name: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number: TS2230L-M Product Descri | April 5, 2024 |
| Z-2065-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 10ML L/L WHITE Model/Catalog Number: 91833 Product Descript | April 5, 2024 |
| Z-2127-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product De | April 5, 2024 |
| Z-2069-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE Model/Catalog Number: 91837 Product Descripti | April 5, 2024 |
| Z-2128-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 91843 Product Descripti | April 5, 2024 |
| Z-2093-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 10ML L/S RED Model/Catalog Number: 91874 Product Descriptio | April 5, 2024 |
| Z-2110-2024 | Class II | Brand Name: GMAX Product Name: SYR 6ML/LL syringe Model/Catalog Number: TS2206L-M Product Descrip | April 5, 2024 |
| Z-2073-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE Model/Catalog Number: 91841 Product Descript | April 5, 2024 |
| Z-2115-2024 | Class II | Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M Product Descri | April 5, 2024 |
| Z-2060-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 5ML L/L WHITE Model/Catalog Number: 91828 Product Descripti | April 5, 2024 |
| Z-2109-2024 | Class II | Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205L-M Product Descrip | April 5, 2024 |
| Z-2080-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 10ML L/L RED HEPARIN Model/Catalog Number: 91851 Product De | April 5, 2024 |
| Z-2043-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: N | April 5, 2024 |
| Z-2051-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 20ML L/S Model/Catalog Number: 83087 Product Description: N | April 5, 2024 |
| Z-2042-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 30ML/LS Model/Catalog Number: 83077 Product Description: NO | April 5, 2024 |
| Z-2047-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 10ML L/L Model/Catalog Number: 83082 Product Description: N | April 5, 2024 |
| Z-2045-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 60ML L/L Model/Catalog Number: 83080 Product Description: N | April 5, 2024 |
| Z-2067-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 20ML L/L RED Model/Catalog Number: 91835 Product Descriptio | April 5, 2024 |
| Z-2056-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 3ML L/L BLUE Model/Catalog Number: 91822 Product Descriptio | April 5, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K200557 | Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) | September 28, 2020 |
| K180259 | Sterile Hypodermic Needle for Single Use | May 18, 2018 |
| K163093 | Safety Blood Collection Set | March 14, 2017 |