Dukal Corp. recalls BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environme…

Recall date

June 1, 2017

Source

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

Recall number

Z-0233-2018

FDA classification

Class II

Brand / firm

Dukal Corp.

Sold / distributed

Worldwide distribution - US Nationwide in the states of: CA, CO, CT, FL, GA, IL, CO, NY, NV, IN, MD, MO, MD OH, TN, TX & WI; and country of Canada

Why it was recalled

Intact carton revealed presence of shredded burn sheets

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

What was recalled

BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection.