Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S
FDA device recall Z-0197-06 · posted 2005-11-24 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MLR
- Quantity affected
- 5365
- Distribution
- Nationwide and Canada, Germany, & Japan. Note: A more detail list of international consignees pending.
- Date initiated
- 2005-09-16
- Date posted
- 2005-11-24
- Date terminated
- 2011-11-21
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STERRAD 100S STERILIZER (K991999) | Advanced Sterilization Products | 2000-06-15 |