Ethicon, Inc. Notifies U.S. Customers About NonSterile Product

Ethicon is notifying purchasers of its NUROLON* Nylon and PERMA-HAND Silk suture brands that it believes two shipper boxes of unfinished product may have left the supply chain prior to sterilization. The unfinished product is labeled as NUROLON* Nylon, product code C522D, lot number CAE 798 and PERMA-HAND* Silk, product code C042D, lot number CAP716. This product is labeled as sterile, but is not sterile and should not be used.

Healthcare providers that purchase Ethicon suture through authorized distribution channels are unlikely to be in possession of this product.

Use of unsterile suture could lead to serious patient consequences, such as clinical infection. For this reason, Ethicon is issuing this notice and asking customers to check their inventories and contact Ethicon at 1-877-ETHICON (1-877-384-4266) if they are in possession of the product codes and lot numbers specified above.

Ethicon has notified the U.S. Food and Drug Administration of this action.