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U.S. Department of Health and Human Services

Class 2 Device Recall STERRAD 100NX

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 Class 2 Recall
STERRAD 100NX
see related information
Date Posted March 30, 2013
Recall Status1 Terminated on September 30, 2013
Recall Number Z-1026-2013
Recall Event ID 64692
Premarket Notification
510(K) Number
K071385 
Product Classification Sterilizer, Chemical - Product Code MLR
Product STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
Code Information SO Numbers: 601918 601921 653618 658412 658619 663775 663605 670265 670983 676483 676976 677247 682484 683535 683401 685051 684706 684897 689791 693170 688731 695253 685242 695044 694872 694890 694933 700374 700420 687958 695322 698794 694561 696647 694903 697444 703236 704953 705019 704220 704997 684009 705131 705189 705395 706157 707254 707928 709374 710904 705394 710055 710381 711947 712233 712952 711466 713603 714781 714896 714927 714941 715465 714230 714936 715319 715471 680655 711359 715140 704508 715994 716005 715655 716503 716506 716482 716806 716925 716956 716977 717350 716504 717332 717457 717466 717456 717490 716774 717477 717487 717482 717472 716955 723403 718518 724650 717455 727905 717473 732354 726771 733003 733007 732940 735456 736315 736250 742622 742112 742351 740419 739924 747572 746618 746545 747670 747711 748911 734951 752042 752042 755131 752064 754673 755986 755473 755926 756407 756812 756765 756999 721585 760939 761382 761772 761799 761633 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Recalling Firm/
Manufacturer
Advanced Sterilization Products
33 Technology Dr
Irvine, California 92618-2346
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Advanced Sterilization Products sent an Urgent Medical Device Field Safety Notification letter dated March 22, 2013 to all customers. The letter identified the affected products, problem and actions to be taken. Customers are instructed to report any complaints or suspected problems with their STERRAD 100NX and/or STERRAD 200 System to ASP Professional Services directly at (888) 783-7723 and select option #2.
Quantity in Commerce 1500 units
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MLR and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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