Customed Inc., Surgical Convenience Packs - Damaged Packaging
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.
The use of affected product may cause serious adverse
health consequences, such as infection and death.