FDAFDA · Food and drugs·Recall number Z-1026-2013
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.
Published April 10, 2013 · Recall initiated: March 22, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Advanced Sterilization Products
- Distributor
- US Nationwide Distribution
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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