Zipline Medical recalls Zip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only, Sterile Indicated for use during and after s…

Recall date

February 5, 2015

Source

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

Recall number

Z-1236-2015

FDA classification

Class II

Brand / firm

Zipline Medical

Sold / distributed

Worldwide Distribution - US Nationwide and the countries of Panama, Tehran, Ireland, Sweden, Japan, Hong Kong, Finland, Pakistan, Taiwan, Malaysia.

Why it was recalled

The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for sterility.

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

What was recalled

Zip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.