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U.S. Department of Health and Human Services

Class 2 Device Recall Advanced Sterilization Products

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 Class 2 Device Recall Advanced Sterilization Productssee related information
Date Initiated by FirmSeptember 16, 2005
Date PostedNovember 24, 2005
Recall Status1 Terminated 3 on November 21, 2011
Recall NumberZ-0197-06
Recall Event ID 33513
510(K)NumberK991999 
Product Classification Sterilizer, Chemical - Product Code MLR
ProductVaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S
Code Information 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  
Recalling Firm/
Manufacturer		 Advanced Sterilization Products
33 Technology Dr
Irvine CA 92618-2346
For Additional Information ContactMizani Kebede
949-789-3922
Manufacturer 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 Determined
Cause 2		Other
ActionThe 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 Commerce5365
DistributionNationwide and Canada, Germany, & Japan. Note: A more detail list of international consignees pending.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MLR
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