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-2124-2024 | Class II | Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-M Product Descrip | April 5, 2024 |
| Z-2102-2024 | Class II | Brand Name: Wolf Medical Product Name: 3 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/ | April 5, 2024 |
| Z-2121-2024 | Class II | Brand Name: GMAX Product Name: SYR 10ML Control syringe Model/Catalog Number: TS3210L-M Product D | April 5, 2024 |
| Z-2087-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE NITRO Model/Catalog Number: 91859 Product De | 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 |
| 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-2106-2024 | Class II | Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model | 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-2123-2024 | Class II | Brand Name: GMAX Product Name: SYR 60ML/LL Blue syringe Model/Catalog Number: TS2260LB-M Product | April 5, 2024 |
| Z-2054-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 3ML L/L RED Model/Catalog Number: 91820 Product Description | April 5, 2024 |
| Z-2097-2024 | Class II | Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L GREEN Model/Catalog Number: 91879 Product De | 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-2128-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 91843 Product Descripti | April 5, 2024 |
| Z-2082-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW LIDO Model/Catalog Number: 91854 Product De | 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-2063-2024 | Class II | Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN Model/Catalog Number: 91831 Product Descript | 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 |