Ethicon Inc., a Johnson & Johnson co., is voluntarily recalling hundreds of thousands of surgical drain products after customers complained that the packaging might not be sterile. The notice on Ethicon's Inc.'s website specifically states, "The company identified the potential for the sterile barrier of the product packaging to be compromised after receiving customer complaints." The company also states that it has not received any reports of adverse events related to this issue, and it has notified the U.S. FDA.
The recall affects multiple lots of Blake Silicone Drains, Blake Silicone Drain Kits, Blake Cardio Connectors, J-VAC Reservoirs and J-VA Drain Adapters, with distribution dates of May 10, 2010 through February 28, 2011. Product codes and lot numbers of products impacted by the recall can be downloaded from the company's website using the following link: http://www.ethicon.com/sites/default/files/pdf/Drains-Reservoirs%20Recall%2032511.pdf
While Ethicon is immediately recommending discontinuing use of affected products, it does stress that the recall is limited to the product names, product codes and lot numbers listed.
Customers are being asked to return impacted products using the products' enclosed prepaid shipping labels. Shipping fees will be charged directly to Ethicon through the use of this shipping label. Replacement product will be issued as the supply of product permits. Credits will be issued if there is no replacement product available.