FDA Device

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

Hazard

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.

What You Should Do

Remedy

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.

Products

Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S
Brand
Advanced Sterilization Products
UPC
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

Units Affected

5365