The Australia Therapeutic Goods Administration (TGA) has issued a medical device safety alert concerning DuraGen Dural Graft Matrix, DuraGen Plus Dural Regeneration Matrix and DuraGen Suturable Dural Regeneration Matrix manufactured by Integra LifeScience Corporation. The affected catalogue numbers are ID-1101-(I), ID-1105-(I), ID-1301-(I), ID-1305-(I), ID-2201-(I), ID-2205-I, ID-3305-(I), ID-4501-(I), DP-1013-I, DP-1022-I, DP-1033-I, DP-1045-I, DP-1057-I, DURS2291, DURS3391 and DURS4591.
Through an internal Quality Assurance review of processes, the manufacturer found that the production process may have deviated during the manufacture of specific lots of product. The product lots in question passed all product finished goods testing, are sterile, and were tested and accepted for endotoxin levels. However, due to the process deviation they may have been released with higher levels of endotoxins than permitted by the specifications for the products.
Integra is recalling the affected products and advises the clinicians to monitor their patients in the postoperative period in accordance with standard hospital or clinician protocol.
For details, please visit the following TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00352-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 April 2013