Recall Z-2114-2024 ยท FMF Syringe, Piston
Jiangsu Shenli Medical Production Co., Ltd.
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
| Date | May 20, 2024 (initiated Apr 5, 2024) |
| Status | Open, Classified |
| Reason | Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). |
| Root cause | No Marketing Application |
| Action | 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 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.