Medline Industries Inc recalls RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30 Pouches per Cas…

Recall date

November 5, 2020

Source

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

Recall number

Z-0615-2021

FDA classification

Class II

Brand / firm

Medline Industries Inc

Sold / distributed

Worldwide distribution - US Nationwide distributions and the countries of Singapore, Denmark, Poland, Portugal, Kenya, Israel, and France.

Why it was recalled

RevMedX Trauma Dressing is being recalled due to package seal integrity.

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

What was recalled

RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30 Pouches per Case; Sterile - Product Usage: are intended to absorb exudates.