Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.

FDA device recall Z-0190-2014 · posted 2013-11-08 · Terminated

Recall details

Recalling firm

Advanced Sterilization Products

Reason for recall

Advanced Sterilization Products (ASP) is recalling the Sterrad 100NX Sterilizer some healthcare workers detected odors/smells emanating from the 100NX Sterilizers, and it may be related to normal breakdown of the oil used in the Sterrad 200 vacuum pumps.

Action taken

A recall letter was sent to all customers on 10/18/13 who purchased the Sterrad 100NX Sterilizer. The letter informed the customers of the problems identified and the actions to be taken. Customers are instructed to contact ASP Professional Services directly at (888) 783-7723 and select option #2. Customers are instructed to report any complaints or suspected problems with their Sterrad 100NX System to Stericycle at (877) 598-5705.

Root cause

Under Investigation by firm

Status

Terminated

Product code

MLR

Quantity affected

2106 units total (1224 units in US)

Distribution

Worldwide Distribution-USA (nationwide) and the countries of EMEA, APAC, Japan, Canada. AE, AU, BE, BH, CA, CH, CL, CN, CO, DE, EC, ES, GB, GR, HK, HU, IL, IN, IT, JP, KR, KW, MX, MY, NX, PA, PH, PK,

Date initiated

2013-10-18

Date posted

2013-11-08

Date terminated

2014-01-16

Location

Irvine, CA