STERRAD NX Sterilizer, Product Code: 10033, Advanced Sterilization Products, Irvine, CA

FDA device recall Z-0848-2008 · posted 2008-02-08 · Terminated

Recall details

Recalling firm

Advanced Sterilization Products

Reason for recall

User Guide Update: based on user reports about contact with residual hydrogen peroxide from instruments, pouches and trays after sterilization and subsequent light colored residue on these devices after sterilization updated user guidance has been issued.

Action taken

Urgent Product Correction letters were sent to customers beginning on November 13, 2007 via UPS overnight. Customers were notified this action was being taken to clarify instructions contained within the STERRAD System User Guides to reinforce appropriate use and to address two separate issues which have arisen from user reports: (1) User reports about contact with residual hydrogen peroxide from instruments, pouches and trays after sterilization. (2) User reports about light-colored residues observed on instruments, trays and pouches after sterilization. The Product Correction Letters instructed customers to refer to the revised excerpt of the User Guide (attached to the letter) for information about instrument preparation prior to sterilization, particularly with regard to the washing, rinsing and thorough drying of instruments prior to sterilization in the STERRAD Sterilization System. If customers have any questions they were instructed to call ASP Customer Care Center to answer additional questions at (888) 783-7723.

Root cause

Employee error

Status

Terminated

Product code

MLR

Quantity affected

9,686 units total for recalls Z-0845-0848-2008

Distribution

Worldwide: USA, France, Germany, Italy, The UK, Switzerland, Benelux, Uruguay, Venezuela, Argentina, Chile, Colombia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indonesia, Mexico, The Philippines, Swit

Date initiated

2007-11-12

Date posted

2008-02-08

Date terminated

2012-03-14

Location

Irvine, CA