Sterrad NX Cassettes recalled by Advanced Sterilization

Timeline

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Advanced Sterilization Products is recalling three lots of STERRAD NX System Cassettes because it does not have adequate data to support the entire duration of the product's labeled shelf-life.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD NX Cassettes are only used in conjunction with the STERRAD NX Sterilization system.

Where it was distributed

Worldwide Distribution - USA (nationwide) and internationally to the following countries: AR, CO, TW, SI, AU, MX, MY, HU, PH, BE, FR, DE, IE, IT, ES, NO, CH, and GB.

Nationwide ArkansasColoradoDelaware

Stores named: Walmart