Class I Recall For Ethicon’s SurgiFlo Due To Potential for Packaging Breach

In short

Ethicon, a division of J&J, has identified an issue in the packaging process for its SurgiFlo haemostatic matrix. It seems certain products, manufactured between September 16 2011 and July 27 2012 are susceptible to a potential breach of the double Tyvek pouch of the packaging.

This defect may cause serious adverse health consequences, including death, which has driven the FDA’s decision to make this a Class I recall.

Background

Ethicon’s SurgiFlo Haemostatic Matrix, mixed with sterile saline or thrombin solution, is used in surgical procedures to stop the flow of bleeding as an adjunct to other techniques. It is a topical, absorbable haemostat, consisting of a paste (flowable gelatin matrix) and a lyophilised Thrombin component. This kit also contains components necessary for preparing and applying the matrix during surgery.

Ethicon sent an Urgent Product Information letter dated August 21, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. In the letter, the company instructed customers to inspect their inventory to determine if they have any of the affected products.

The full recall notice, including details of affected lots can be found here.

Source: FDA