AROA BIOSURGERY recalls Endoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal Template is a sterile, single use ovine foresto…

Recall date

November 27, 2018

Source

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

Recall number

Z-0379-2019

FDA classification

Class II

Brand / firm

AROA BIOSURGERY

Sold / distributed

US Nationwide Distribution

Why it was recalled

Potential for pouch seal failure

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

What was recalled

Endoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.