Jiangsu Shenli Medical Production Co. product recalled over sterility concerns

Recall date

April 5, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: Wolf Medical - WOLF-PAK Product Name: DISPOSABLE SYRINGE 1 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGEN…

Recall number

Z-2101-2024

FDA classification

Class II

Brand / firm

Jiangsu Shenli Medical Production Co., Ltd.

Sold / distributed

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 a…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brand Name: Wolf Medical - WOLF-PAK Product Name: DISPOSABLE SYRINGE 1 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR01L Serial Number: 850007185411 Product Description: NON-Sterile syringes without needles for single use Component: No