• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall STERRAD 100NX

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device 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
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
761658
761800
763129
764141
765734
761630
766501
766267
766428
767666
768281
771414
771584
774002
773999
760959
747284
776722
776662
776977
773450
777395
777350
766566
777994
778115
778295
778306
778397
778420
780632
779184
784712
784835
789915
790515
792749
793716
794027
797344
798207
801358
801676
801385
805783
806315
806548
806498
806984
806802
808292
808295
808494
808536
809391
809380
797623
810329
817633
798012
825076
828243
830038
830794
831189
836405
837375
838142
839868
839929
817131
839929
840983
840545
841232
809230
842623
842322
843316
843497
823885
819965
843666
843851
843787
818045
843499
844166
844051
844190
845657
844485
848549
849523
849499
849527
849527
849499
851457
852003
849523
852405
856503
859597
860435
861720
861917
862005
863791
863870
864038
863842
865068
865076
867636
868287
869093
871827
871790
863050
873698
873698
874387
874466
874728
876106
876624
876807
877651
813836
877789
877576
878774
878774
881729
881738
887762
887978
889727
891300
895873
895176
896768
895849
898137
897959
898145
898144
899398
898149
904691
891940
907321
902481
907311
906496
904826
908653
908556
907321
906145
909224
909224
910299
910299
911887
909596
910331
915296
907761
909869
896805
910230
914469
914354
914672
911878
914763
914763
918228
917891
918278
919687
919759
893458
915478
915278
914677
913037
913938
917651
919168
919168
918530
917793
918325
927487
927447
923029
935769
941048
943441
944176
930844
950772
952012
952012
954901
947983
947838
949387
937824
919745
917794
917794
940527
959319
934494
942257
957255
936015
936015
942702
939355
937838
947613
930178
962909
944501
949633
950617
964028
952061
950943
951570
951571
952057
965762
971049
978087
981509
968850
968850
967627
978551
983052
984117
977230
973810
973810
977039
980603
951581
987939
975238
975250
989458
945148
975582
975043
988783
977293
986464
977850
954788
992676
992676
995167
995315
971479
978738
997345
989898
1000964
1000054
982828
985179
983132
986904
1009960
997060
1003310
994427
989325
989897
989887
988720
1001446
999609
989887
996490
1007883
989799
989128
1017330
1014929
1001454
989812
964035
1001445
1001445
1000552
1007891
986668
999879
1006666
1006666
1006666
1000578
957170
989318
989318
1001413
1012992
1008806
1006163
1023238
1024407
1001448
1001466
1003454
1012986
1040231
989220
1041871
1001456
1001457
1001457
1001410
1001355
1012173
988695
1054423
992073
993189
1001274
1053410
1044991
1044991
1020584
1012923
1063598
1063609
1025584
1024164
1027213
1031944
1039441
1044876
1059351
1063083
1050309
1025247
10226
Recalling Firm/
Manufacturer
Advanced Sterilization Products
33 Technology Dr
Irvine CA 92618-2346
949-453-6400
For Additional Information Contact
949-453-6400
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
Nonconforming Material/Component
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
-
-