Jiangsu Shenli Medical Production Co., Ltd.: Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR35L Product Description: NON-Sterile

Hazard

Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).

Details from the source

Reason for recall: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k). 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: 483210 Lot/code info: Lot Code: LOT: 20190517, 20191014, 20200204, 20200301, 20210301, 20210901, 20211112, 20220414, 20220614, 20221015, 20231006

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.