Jiangsu Shenli Medical Production Co., Ltd.

FDA Regulatory Profile

Jiangsu Shenli Medical Production Co., Ltd. appears in FDA public data with 87 recalls, 3 510(k) clearances, 3 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-2065-2024, Class II) was initiated on April 5, 2024. Its most recent 510(k) clearance was granted on September 28, 2020.

Summary

Total Recalls
87
510(k) Clearances
3
Inspections
3
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-2065-2024Class IIBrand Name: MEDLINE Product Name: SYR 10ML L/L WHITE Model/Catalog Number: 91833 Product DescriptApril 5, 2024
Z-2106-2024Class IIBrand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC ModelApril 5, 2024
Z-2069-2024Class IIBrand Name: MEDLINE Product Name: SYR 20ML L/L BLUE Model/Catalog Number: 91837 Product DescriptiApril 5, 2024
Z-2123-2024Class IIBrand Name: GMAX Product Name: SYR 60ML/LL Blue syringe Model/Catalog Number: TS2260LB-M Product April 5, 2024
Z-2054-2024Class IIBrand Name: MEDLINE Product Name: SYR 3ML L/L RED Model/Catalog Number: 91820 Product DescriptionApril 5, 2024
Z-2087-2024Class IIBrand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE NITRO Model/Catalog Number: 91859 Product DeApril 5, 2024
Z-2093-2024Class IIBrand Name: MEDLINE Product Name: SYR 10ML L/S RED Model/Catalog Number: 91874 Product DescriptioApril 5, 2024
Z-2110-2024Class IIBrand Name: GMAX Product Name: SYR 6ML/LL syringe Model/Catalog Number: TS2206L-M Product DescripApril 5, 2024
Z-2049-2024Class IIBrand Name: MEDLINE Product Name: SYR 3ML L/L Model/Catalog Number: 83084 Product Description: NOApril 5, 2024
Z-2077-2024Class IIBrand Name: MEDLINE Product Name: SYR 10ML L/L BLUE LIDO Model/Catalog Number: 91847 Product DescApril 5, 2024
Z-2119-2024Class IIBrand Name: GMAX Product Name: SYR 20ML/LS syringe Model/Catalog Number: TS2220S-M Product DescriApril 5, 2024
Z-2067-2024Class IIBrand Name: MEDLINE Product Name: SYR 20ML L/L RED Model/Catalog Number: 91835 Product DescriptioApril 5, 2024
Z-2082-2024Class IIBrand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW LIDO Model/Catalog Number: 91854 Product DeApril 5, 2024
Z-2058-2024Class IIBrand Name: MEDLINE Product Name: SYR 5ML L/L GREEN Model/Catalog Number: 91826 Product DescriptiApril 5, 2024
Z-2079-2024Class IIBrand Name: MEDLINE Product Name: SYR 10ML L/L RED LIDO Model/Catalog Number: 91850 Product DescrApril 5, 2024
Z-2060-2024Class IIBrand Name: MEDLINE Product Name: SYR 5ML L/L WHITE Model/Catalog Number: 91828 Product DescriptiApril 5, 2024
Z-2080-2024Class IIBrand Name: MEDLINE Product Name: SYR 10ML L/L RED HEPARIN Model/Catalog Number: 91851 Product DeApril 5, 2024
Z-2043-2024Class IIBrand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NApril 5, 2024
Z-2042-2024Class IIBrand Name: MEDLINE Product Name: SYR 30ML/LS Model/Catalog Number: 83077 Product Description: NOApril 5, 2024
Z-2056-2024Class IIBrand Name: MEDLINE Product Name: SYR 3ML L/L BLUE Model/Catalog Number: 91822 Product DescriptioApril 5, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K200557Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)September 28, 2020
K180259Sterile Hypodermic Needle for Single UseMay 18, 2018
K163093Safety Blood Collection SetMarch 14, 2017