FDA Medical Device Recalls (openFDA)
Advanced Sterilization Products: STERRAD 200 Sterilizer, Product Code: 10201, Advanced Sterilization Products, Irvine, CA
- Recall number
- Z-0847-2008
- Recalling firm
- Advanced Sterilization Products
- Product
- STERRAD 200 Sterilizer, Product Code: 10201, Advanced Sterilization Products, Irvine, CA
- Status
- Terminated
- Initiated
- 2007-11-12
- Posted
- 2008-02-08
- Terminated
- 2012-03-14
- Reason
- 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.
- Root cause
- Employee error
- Action
- 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.
- Quantity
- 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, Switzerland, Australia, Austria, China, Greece, Ireland, Israel, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, Turkey, Middle East, Peru, Canada, The Czech Republic, Middle East, Portugal, S Africa, Spain, Sweden, Hungary, Poland, Brazil, Russia, Egypt, India & Slovenia
- Lot, serial or model codes
- All Serial Numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MLR
- Firm FEI
- 3003662624
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28