Jiangsu Shenli Medical Production Co., Ltd. Recall 94520
Description: Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co., Ltd. Recall 94520 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2115-2024 |
| Event ID | 94520 |
| Event Description | Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M Product Description: NON-Sterile syringes without needles for single use Component: No |
| Product Type | Devices |
| 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. |
| Quantity | 7750 |
| Recall Reason | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). |
| Device Classification | 20240529 |
| Device Code Info | Lot Code: LOT: SL22070111,SL22100211,SL23080310 |
| Center Classification Date | 20240610 |
| Recall Initiation Date | 20240405 |
| Recalling Firm | Jiangsu Shenli Medical Production Co., Ltd. |
| Initial Notification | |
| Similar To |