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 says, "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.
BLAKE® Silicone Drain
BLAKE® Silicone Drain Kit
BLAKE® Cardio Connector
J-VAC™ Drain Adapter