Reason for Recall: Surgical pack sterility may be compromised due to individual packs adhering to one another inside the shipping case.  In some cases, the plastic packaging of one bag (along the printed words “SNAP SMARTLY TO OPEN”) has adhered to the end seal of an adjacent pack.  When the bags are separated, the plastic film can tear and compromise the sterility of the contents.

There is significant risk of compromised sterility and use of a contaminated product, whether the package is damaged or not.  The products have been exposed to uncontrolled and inadequate storage conditions and there are serious deficiencies in the manufacturing process.