Teleflex MEDICAL WECK Visistat 35 recalled over laceration hazard

Recall date

February 15, 2018

Source

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

Official notice title

Teleflex Medical recalls Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.

Recall number

Z-1193-2018

FDA classification

Class II

Brand / firm

Teleflex Medical

Sold / distributed

KS

Why it was recalled

Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 individually packaged units within the boxes are correctly labeled.

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

What was recalled

Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.