Z-0197-06

Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S

Name: Z-0197-06 Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S
Creator: Advanced Sterilization Products
Published: 2005-09-16
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2005-09-16 / Terminated

FDA source

Advanced Sterilization Products began a recall of Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S on 2005-09-16. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0197-06
Status: Terminated
Initiated: 2005-09-16
Posted: 2005-11-24
Terminated: 2011-11-21
Recalling firm: Advanced Sterilization Products
Product: Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S
Product code: MLR Sterilizer, Chemical
Reason for recall: 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.
FDA 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 in commerce: 5365
Distribution: Nationwide and Canada, Germany, & Japan. Note: A more detail list of international consignees pending.
Product codes and lots: 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

Product code MLR

K991999Class IISterrad 100S SterilizerAdvanced Sterilization Products / cleared 2000-06-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)