Recall Z-2114-2024
Jiangsu Shenli Medical Production Co., Ltd. · initiated April 5, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Brand Name: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number: TS2230L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Codes / lots: Lot Code: LOT: SL21030107,SL21040107,SL21070107,SL21090108,SL21110107,SL21 110203,SL21110305,SL21120107,SL22030108,SL22080105,SL221002 09,SL22120206,SL23020207,SL23040207,SL23080309,SL23100409, SL23120408
Reason for recall
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
FDA-determined cause: No Marketing Application
Action taken
On 05/14/2024, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter informing customers that Jiangsu Shenli Medical Production Co., Ltd. is recalling piston syringes that were distributed without premarket clearance. The Recalling Firm stated that they received an FDA Warning Letter that the piston syringes were not legally marketed devices. Customers are instructed to: Examine their inventory and stop/cease use of all syringe products subject to this action and report the inventory quantity to Jiangsu Shenli Medical Production Co., Ltd. Considering the complicated return process, and high cost of returning the products, the firm is instructing customers to dispose of these recalled syringes in the U.S, using their facility s approved/established procedures for disposal of medical products, or by contacting a local third party company to assist with the disposal of the recalled syringes. Please report the destruction method and cost with Shenli before final implementation. After product disposal, please provide Shenli with confirmation of destruction of products. For questions or assistance - contact the general manager at email shenli@syringechina.com or telephone number 0086-519-88731071
Details
- Recall number
- Z-2114-2024
- Initiated
- April 5, 2024
- Posted by FDA
- May 20, 2024
- Product code
- FMF – Syringe, Piston
- Quantity
- 1117500
- Distribution
- U.S. Nationwide distribution in the states of CA, FL, GA, IL, TN, and VA. After customers place US orders, then arrange production, then deliver to the cargos to customer designated port or warehouse, mostly in Shanghai port. The shipping company will ship the cargos to different destination such as Chicago, Los Angeles, Long beach, Miami, Savannah, Nashville, and Norfolk.
- Recalling firm
- Jiangsu Shenli Medical Production Co., Ltd., Changzhou
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2042-2024 Class II | Brand Name: MEDLINE Product Name: SYR 30ML/LS Model/Catalog Number: 83077 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2043-2024 Class II | Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2044-2024 Class II | Brand Name: MEDLINE Product Name: SYR 60ML L/S Model/Catalog Number: 83079 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2045-2024 Class II | Brand Name: MEDLINE Product Name: SYR 60ML L/L Model/Catalog Number: 83080 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2046-2024 Class II | Brand Name: MEDLINE Product Name: SYR 10ML L/S Model/Catalog Number: 83081 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2047-2024 Class II | Brand Name: MEDLINE Product Name: SYR 10ML L/L Model/Catalog Number: 83082 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2048-2024 Class II | Brand Name: MEDLINE Product Name: SYR 3ML L/S Model/Catalog Number: 83083 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2049-2024 Class II | Brand Name: MEDLINE Product Name: SYR 3ML L/L Model/Catalog Number: 83084 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2050-2024 Class II | Brand Name: MEDLINE Product Name: SYR 5ML L/S Model/Catalog Number: 83085 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2051-2024 Class II | Brand Name: MEDLINE Product Name: SYR 20ML L/S Model/Catalog Number: 83087 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2052-2024 Class II | Brand Name: MEDLINE Product Name: SYR 20ML L/L Model/Catalog Number: 83088 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2053-2024 Class II | Brand Name: MEDLINE Product Name: SYR 1ML TB Model/Catalog Number: 83089 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2054-2024 Class II | Brand Name: MEDLINE Product Name: SYR 3ML L/L RED Model/Catalog Number: 91820 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2055-2024 Class II | Brand Name: MEDLINE Product Name: SYR 3ML L/L GREEN Model/Catalog Number: 91821 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2056-2024 Class II | Brand Name: MEDLINE Product Name: SYR 3ML L/L BLUE Model/Catalog Number: 91822 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2057-2024 Class II | Brand Name: MEDLINE Product Name: SYR 5ML L/L RED Model/Catalog Number: 91825 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2058-2024 Class II | Brand Name: MEDLINE Product Name: SYR 5ML L/L GREEN Model/Catalog Number: 91826 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2059-2024 Class II | Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE Model/Catalog Number: 91827 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2060-2024 Class II | Brand Name: MEDLINE Product Name: SYR 5ML L/L WHITE Model/Catalog Number: 91828 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2061-2024 Class II | Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW Model/Catalog Number: 91829 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2062-2024 Class II | Brand Name: MEDLINE Product Name: SYR 10ML L/L RED Model/Catalog Number: 91830 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2063-2024 Class II | Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN Model/Catalog Number: 91831 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2064-2024 Class II | Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE Model/Catalog Number: 91832 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2065-2024 Class II | Brand Name: MEDLINE Product Name: SYR 10ML L/L WHITE Model/Catalog Number: 91833 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2066-2024 Class II | Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW Model/Catalog Number: 91834…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2067-2024 Class II | Brand Name: MEDLINE Product Name: SYR 20ML L/L RED Model/Catalog Number: 91835 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2068-2024 Class II | Brand Name: MEDLINE Product Name: SYR 20ML L/L GREEN Model/Catalog Number: 91836 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2069-2024 Class II | Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE Model/Catalog Number: 91837 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2070-2024 Class II | Brand Name: MEDLINE Product Name: SYR 20ML L/L WHITE Model/Catalog Number: 91838 Product…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |
| Z-2071-2024 Class II | Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW Model/Catalog Number: 91839…Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). | 04/05/2024Open, Classified |