ETHICON Products has discovered that some lots of Surgical Gut Suture potentially may have an overwrap seal anomaly. While the seal on the suture packet inside the overwrap is not compromised in any way, we cannot guarantee the sterility of the outer surface of the sealed foil packet, so we are voluntarily recalling certain lots from the market.
While our health effects assessment indicates that there is a low probability of adverse health consequences in patients who may have undergone a procedure using this product, we believe it is prudent to recall the affected products. Procedures for obtaining affected sutures are underway.