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Recall Observatory FDA recall evidence

Device product

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.

Z-0661-2013

September 20, 2012

Class II

Product summary

Firm
Advanced Sterilization Products
Event
Event 63877
Status
Terminated
Classification
Class II
Quantity
12,280 units
Official record key
device-enforcement:Z-0661-2013

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.