Recall Z-0197-06 ยท MLR Sterilizer, Chemical
Advanced Sterilization Products
Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S
| Date | Nov 24, 2005 (initiated Sep 16, 2005) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991999 | STERRAD 100S STERILIZER Advanced Sterilization Products, Jun 15, 2000 |