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Terminated

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

FDA Recall Z-0197-06 · Posted 2005-11-24

Recalling FirmAdvanced Sterilization Products
Recall StatusTerminated
Product CodeMLR
Date Initiated2005-09-16
Date Terminated2011-11-21
Product Quantity5365

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide and Canada, Germany, & Japan. Note: A more detail list of international consignees pending.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991999STERRAD 100S STERILIZERAdvanced Sterilization Products · 2000-06-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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