STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers u

FDA device recall Z-0661-2013 · posted 2013-01-09 · Terminated

Recall details

Recalling firm

Advanced Sterilization Products

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.

Action taken

Advanced Sterilization Product sent an Urgent Medical Device Recall (Removal) letter dated December 4, 2012, to all affected customers. The letter informed the customers that the Sterrad NX Cassettes do not have adequate data to support the entire duration of the product's labeled shelf-life. Customers are instructed of the problems identifed and the actions to be taken. Customers are instructed to notify their customers if they have further distributed the recalled products and to have them contact Stericycle at (877) 650-7686 to arrange for return of the product. Customers with questions are instructed to call Stericycle at (877) 650-7686 Mon-Fri from 8am to 5pm, ET. For questions regarding this recall call 949-453-6400.

Root cause

Labeling design

Status

Terminated

Product code

MLR

Quantity affected

12,280 units

Distribution

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.

Date initiated

2012-09-20

Date posted

2013-01-09

Date terminated

2013-10-17

Location

Irvine, CA