ShinChang Medical Co., Ltd. recalls Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a…

Recall date

August 24, 2018

Source

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

Recall number

Z-3202-2018

FDA classification

Class II

Brand / firm

ShinChang Medical Co., Ltd.

Sold / distributed

FL, TN, and VA

Why it was recalled

Defect consists of a small crack in the top end of the barrel near the needle.

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

What was recalled

Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a flexible plastic (poly bag) and 10 flexible plastic (poly bag) are packaged in one in box. Finally, pack the inboxes in the carton case.)