Warning
Davol Recalls Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1896-2026Medical Device
Davol Recalls Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6
Davol, Inc. · Class II — Moderate Risk
Product Description
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
Reason for Recall
Potential for product to contain foreign matter, confirmed to be inspect fragments.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Worldwide distribution - US Nationwide and the countries of China, South Korea.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database