FDA Medical Device Recalls (openFDA)
Advanced Sterilization Products: Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S
- Recall number
- Z-0197-06
- Recalling firm
- Advanced Sterilization Products
- Product
- Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S
- Status
- Terminated
- Initiated
- 2005-09-16
- Posted
- 2005-11-24
- Terminated
- 2011-11-21
- Reason
- The STERRAD 100 and the STERRAD 100S vaporizer plates are prone to displacement allowing micro-droplets of H2O2 to contact the load. If the vaporizer plate is dislodged, there is an increased chance for operators to have contact with H2O2 resulting in transient burns during the removal of the load.
- Root cause
- Other
- Action
- The recall strategy consists of supplying each customer of the STERRAD 100 and the STERRAD 1OOS with: a notification letter of the field action (mailed 09/22/05 ), a pack containing two vaporizer plates of the newly released design, and a set of instructions for self-installation.
- Quantity
- 5365
- Distribution
- Nationwide and Canada, Germany, & Japan. Note: A more detail list of international consignees pending.
- Lot, serial or model codes
- 20220 STERRAO 100 Accessory Kit 1.8 20221 STERRAO 100 Accessory Kit 2.0 20222 STERRAO 100 Accessory Kit 2.0 Same as 20221 except single ply paper 20223 STERRAO 1 DOS Accessory Kit A (For use with Block 1.8 STERRAO 100S) 20224 STERRAO 1 DOS Accessory Kit B (For use with Block 2.0 STERRAO 1 DOS) 20225 STERRAO 100S Accessory Kit C (For use with Block 2.0 STERRAO System & Block 1.8 STERRAO with Printer UpQrade kit install 03-53045- 1- 001 Vaporizer Plate, Shelf Pac 03-05660- 0- 001
- 510(k) numbers
- ["K991999"]
- 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