Wolf, Henke Sass, Gmbh recalls Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous…

Recall date

July 27, 2023

Source

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

Recall number

Z-2642-2023

FDA classification

Class II

Brand / firm

Wolf, Henke Sass, Gmbh

Sold / distributed

Worldwide distribution - US Nationwide and the country of Canada.

Why it was recalled

Sterile barrier might be damaged compromising the sterility of the device.

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

What was recalled

Henke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular, subcutaneous, intracutaneous and intraarterial injection of liquids or diluted drugs in combination with an adequate medical device or for withdrawal of fluids from the body. Ref: 4100.000V0