Jiangsu Shenli Medical Production Co., Ltd.: Brand Name: Wolf Medical - WOLF-PAK Product Name: DISPOSABLE SYRINGE 1 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR01L Seri

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: 1001900 Lot/code info: Serial Number: 850007185411 Lot Code: LOT: 20210430

UPC codes

850007185411

Source

Official record: FDA (Device enforcement) ↗

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