Art-Line Surgery Pack-LF recalled over sterility concerns

Recall date

April 12, 2017

Source

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

Official notice title

Medline Industries, Inc. recalls Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.

Recall number

Z-2976-2018

FDA classification

Class II

Brand / firm

Medline Industries, Inc.

Sold / distributed

CA, NM

Why it was recalled

Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit component #52655) attached to the outside of the sterile pack. This may pose potential risk of infection. However, the kits have been in distribution since March 2016. Many of these kits have been used with no reported infections or adverse patient events. In addition, the BIOPATCH is impregnated with CHG, a well-known antiseptic agent with broad-spectrum anti-microbial and antifungal activity.

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

What was recalled

Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.