There is a potential for a sterile barrier breach due to a packaging issue. Specifically, an issue identified in the product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner tyvek pouch, which contains the sterile product. As a result of the breached foil pouch, the sterile field may be contaminated by the outside of the inner pouch. Recall Start Date: August 12, 2024
RecallTracker