Advanced Sterilization Products: Medical Device Recall in 2013 - (Recall #: Z-0661-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 20, 2012

Date Posted: January 16, 2013

Recall Number: Z-0661-2013

Event ID: 63877

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.

Status: Terminated

Product Quantity: 12,280 units

Code Information:

Lot # 11J037, 11L038, 11J033

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated