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AROA BIOSURGERY recalls Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine fore
Recalled November 14, 2018 · FDA recall Z-0378-2019 · AROA BIOSURGERY
Hazard
Potential for pouch seal failure · FDA Class II
Units
8,853 total boxes
Sold at
US Nationwide Distribution
Description
Potential for pouch seal failure
Product
Endoform Dermal Template 2x2, SKU 529312 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.
Manufacturer(s)
AROA BIOSURGERY
Made in
New Zealand
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →