Medical device manufacturer, CryoLife has issued a field safety notice concerning its BioGlue Surgical Adhesive 5mL (Product Code: BG3515-5).
At the request of the United States Food and Drug Administration, the manufacturer has changed the expiration dating for the product from 24 months to 18 months due to the fact that the serum albumin component monomer failed to meet the manufacturer's internally established end of shelf-life specification.
Based on the manufacturer's health risk assessment, serum albumin monomer content below specification does not impose any change in patient risk to the delivered product.
The manufacturer has advised users in the United States to either return or re-label the affected products.
According to the local supplier, IntegMed Ltd., the affected products were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 13 June 2014