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U.S. Department of Health and Human Services

Class 2 Device Recall The STERRAD Sterilization System

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  Class 2 Device Recall The STERRAD Sterilization System see related information
Date Initiated by Firm September 18, 2013
Date Posted October 22, 2013
Recall Status1 Terminated 3 on April 11, 2014
Recall Number Z-0043-2014
Recall Event ID 66328
510(K)Number K030429  
Product Classification Sterilizer Chemical - Product Code MLR
Product STERRAD 200 Sterilizer (Single Door), Part Number: 10201.
STERRAD 200 Sterilizer (Double Door), Part Number: 10202.

The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Code Information Lot A: 0009*ENG 0003*FG 0048*FG 0050*MRB      0237*YAMATO 0239*YAMATO  0097*FSRIP  0097*FG 315*TTL 316*TTL 317*TTL 318*TTL 314*FG 325*TTL  326*TTL 334*FG 335*FG  329*TTL   345*TTL 357*FG 359*FG  358*FG 344*TTL 351*FG   347*TTL  352*TTL   348*TTL  348*FG 360*TTL 361*TTL  364*FG 362*TTL 383*YAMATO 365*TTL 368*TTL 371*FG 369*TTL 370*TTL  374*TTL 378*TTL 379*TTL 397*TTL 376*TTL  398*TTL  400*TTL    401*TTL 402*TTL 386*TTL    403*TTL 404*TTL 406*TTL 405*TTL 399*TTL 419*TTL 388*TTL 420*TTL 421*TTL 0239*CD33 422*TTL 423*TTL  429*YAMATO 424*TTL 439*YAMATO 425*TTL 427*TTL 346*TTL  423*TTL 372*TTL 430*TTL 428*TTL 395*TTL 431*TTL 433*TTL 447*YAMATO 432*TTL  434*TTL 435*TTL 437*TTL 436*TTL 453*YAMATO 454*YAMATO 452*YAMATO 440*TTL 412*TTL  455*YAMATO   456*YAMATO  468*FG 460*FG 458*FG 459*FG 462*FG 463*FG 464*FG 473*FG 470*FG 465*FG  488*YAMATO  476*FG 481*FG 487*YAMATO 502*FG 482*FG 501*FG 484*FG 485*FG 486*FG 483*FG 479*TTL 493*FG 492*FG 495*YAMATO 494*FG 509*YAMATO 504*TTL 503*TTL 505*TTL  506*TTL  507*TTL 512*TTL 524*TTL    540*YAMATO  538*YAMATO 539*YAMATO  537*YAMATO 541*YAMATO 508*TTL 520*TTL 519*TTL 518*TTL 516*TTL  521*TTL 522*TTL 523*TTL 556*TTL 525*TTL 526*TTL 524*TTL 528*TTL 529*TTL 530*TTL 532*TTL 531*TTL 515*FG 533*TTL 534*TTL 535*TTL 557*TTL 536*TTL  568*YAMATO  570*YAMATO 575*YAMATO 543*TTL 545*TTL 544*TTL 571*YAMATO 546*TTL 548*TTL 547*TTL 549*TTL 550*TTL 554*TTL 553*TTL 552*TTL 558*TTL 555*TTL 581*YAMATO 559*TTL 560*TTL 561*TTL 585*YAMATO 562*TTL 563*TTL 576*TTL 579*TTL   593*TTL 595*TTL  591*YAMATO 590*YAMATO 596*FG 597*TTL 606*YAMATO 602*TTL 601*TTL 599*TTL 598*TTL  607*YAMATO 604*TTL 603*TTL 612*FG 616*YAMATO  611*TTL 628*TTL 615*TTL 629*TTL 632*TTL   630*TTL 631*TTL 605*TTL 625*YAMATO 621*YAMATO 643*TTL 633*TTL 644*TTL 645*TTL 656*TTL 652*TTL 655*TTL  658*TTL 646*TTL 654*FG 659*FG 660*TTL 662*TTL 680*TTL 663*TTL 665*TTL 666*TTL 664*TTL 667*TTL 683*TTL 685*TTL 686*TTL 684*TTL 650*YAMATO  620*YAMATO 653*TTL 679*TTL 682*TTL  690*TTL 692*TTL 691*TTL 693*TTL 694*TTL 695*TTL 696*TTL 689*TTL 688*TTL 687*TTL 661*TTL 703*TTL 699*TTL 697*YAMATO 706*TTL 705*TTL 704*TTL  707*TTL 708*TTL 709*TTL 710*TTL 722*TTL 717*TTL 716*TTL 712*TTL 715*TTL 725*TTL 726*TTL 711*TTL 714*TTL 718*TTL 719*TTL 721*TTL 723*TTL 727*TTL 641*TTL 728*TTL 729*TTL 731*TTL 732*TTL 713*TTL 737*TTL 734*TTL 735*TTL 736*TTL  724*TTL 730*TTL 733*TTL 642*TTL 738*TTL 740*TTL 739*TTL  741*TTL 742*TTL 743*TTL 744*TTL 745*TTL 746*TTL 747*TTL 748*TTL 749*TTL 750*TTL 751*TTL 754*TTL 755*TTL 756*TTL 648*YAMATO 758*TTL 757*TTL 759*TTL 762*TTL 761*TTL 763*TTL 764*TTL 765*TTL 698*YAMATO 675*YAMATO 766*TTL 767*TTL 768*TTL 779*TTL 780*TTL 781*TTL 782*TTL 783*TTL 770*YAMATO  784*TTL  785*TTL 786*TTL  788*TTL         637*TTL 791*TTL 793*TTL 792*TTL 787*TTL  790*TTL 790*TTL 794*TTL 796*TTL 795*TTL 797*TTL 798*TTL 800*TTL 802*TTL 801*TTL 803*TTL 804*TTL 805*TTL 806*TTL 807*TTL    808*TTL 809*TTL 810*TTL 811*FG 813*TTL        814*TTL   815*TTL 673*YAMATO 816*TTL  817*TTL 818*TTL   819*TTL 884*YAMATO   822*TTL 824*TTL 821*TTL   820*FG 823*TTL 825*TTL 826*TTL  883*TTL 828*TTL 829*TTL                      812*TTL 832*TTL 830*TTL 831*TTL 839*TTL 833*TTL 841*TTL 840*TTL 846*TTL 847*TTL 845*TTL 844*TTL 842*TTL 827*TTL 811*TTL 848*TTL 849*TTL 850*TTL   875*YAMATO 870*YAMATO 856*TTL 855*TTL 853*TTL 852*TTL 851*TTL 858*TTL 863*TTL 862*TTL 861*TTL 859*TTL 864*TTL  860*TTL 865*TTL 867*TTL 866*TTL 890*TTL 868*TTL 903*TTL 901*TTL 899*TTL 891*TTL 897*TTL 890*TTL 896*TTL  892*TTL  893*TTL 894*TTL 885*TTL 889*TTL 904*TTL 905*TTL 902*TTL 908*TTL  907*TTL  909*TTL 906*TTL 910*TTL 912*TTL 911*TTL 914*TTL 913*TTL 915*TTL  916*TTL 918*TTL 917*TTL 920*TTL 919*TTL 877*YAMATO 922*TTL 835*YAMATO 923*TTL 927*TTL 926*TTL 925*TTL 924*TTL 928*TTL 931*TTL 932*TTL 838*YAMATO 934*TTL 967*FG 935*TTL 936*TTL 938*TTL        939*TTL 945*TTL 947*TTL 940*TTL 946*TTL  950*TTL 973*TTL 950*TTL 976*TTL 951*TTL 974*TTL 984*TTL 949*FG 953*TTL  978*TTL 982*TTL 986*TTL 994*TTL 995*TTL 996*TTL 954*TTL 955*TTL 956*TTL  957*TTL  0201080042*  0201080027* 0201080041* 958*  959* 960* 961* 962*  975* 972* 971* 977* 985* 0201080051* 0201080052* 0201080045*  0201080055* 0201080053*  0201080054* 0201080044*  0201080057* 0201080046* 0201080061* 0201080063* 0201080062*  0201080031* 0201080039*  0201080040* 0201080035* 0201080065*  0201080064*  0201080074* 0201080072* 0201080073* 0201080069* 0201080070*  0201080066* 0201080048* 0202100004* 0201080075* 0201080077* 0201080076* 330*YAMATO  0137*FG 0136*FG  333*YAMATO   0139*FG 0097*FSRIP 194*FG 0130*FG  0135*FG   0260*YAMATO  0261*YAMATO   0201100001*    0058*FG 0064*FG  514*YAMATO 0202100030* 0202100032* 0202100033* 0202100034* 0202100035* 0202100036* 0202100037* 0202100045* 0141*FG 0195*FGYAMATO 0192*FGYAMATO 331*YAMATO   332*YAMATO   394*TTL  0202090032* 0202090036* 0202090038* 0202090039* 0202090040* 0202080018* 0202090001*  0232*YAMATO 0262*YAMATO  0070*FG 0071*FG   879*YAMATO 0193*FGYAMATO   753*YAMATO 752*YAMATO 0202100054* 0202100001* 0067*FG  0263*YAMATO  0199*FGYAMATO 0143*FG    0200*FGYAMATO 0072*FG 0066*FG  0201*FGYAMATO   887*YAMATO 887*YAMATO  0065*FG 0068*FG 0067*FG 0069*FG 0070*FG 0071*FG  0072*FG  0202*FGYAMATO 0202090003* 0202090008* 0202090034* 0202090007*  0265*YAMATO    0202090005*  0056*FG    0197*YAMATO 0207*YAMATO   0271*YAMATO               413*YAMATO 198*TTL 210*TTL 209*TTL  0265*FG        0266*YAMATO 264*YAMATO   204*TTL 203*TTL 0273*YAMATO 0272*YAMATO 0270*YAMATO   0212*YAMATO 0205*YAMATO 769*YAMATO   0202090010*  0211*YAMATO    0213*YAMATO 0202100002* 672*YAMATO 0216*YAMATO 0202100021* 0202100026* 0202100027* 0202100028* 0202100046* 0202100047* 0202100055* 0202100056*      336*TTL  0144*FG 441*YAMATO    339*TTL 0218*YAMATO 0217*YAMATO  0279*YAMATO 0275*YAMATO  340*TTL  0147*FG    343*FG  341*TTL 342*YAMATO   219*TTL    874*YAMATO 0155*FG  442*YAMATO 564*TTL   0223*YAMATO 0221*YAMATO 0220*YAMATO  0146*FG 565*TTL  0221*TTL 0201100002*     0202090012*   449*YAMATO   578*YAMATO 0076*FG 0145*FG 0156*FG     277*YAMATO    274*TTL 0224*YAMATO      0225*YAMATO  0222*YAMATO 276*YAMATO  0202090017* 0080*FG 0079*FG 353*TTL  0201080023* 775*YAMATO   0086*FG 0082*FG 0151*FG 0157*FG 0226*YAMATO 880*YAMATO   445*YAMATO 0202090024*   285*YAMATO 281*YAMATO 514*FG 0201080032* 0202090011* 582*FG 0202100020* 0202100040* 0202100041* 0202100053* 284*YAMATO 280*YAMATO 282*YAMATO  0246*YAMATO  0083*FG 0087*FG  356*TTL 446*YAMATO 584*YAMATO 944*YAMATO 0087*FG 777*YAMATO 771*YAMATO 514*FG  228*YAMATO    227*YAMATO 586*YAMATO 0202100007* 0201100003* 0201100004* 987*YAMATO 0202100006*   363*FG 0229*YAMATO 0233*YAMATO 286*YAMATO 291*YAMATO 0230*YAMATO 0234*YAMATO  0201080034*      588*YAMATO   0161*FGYAMATO 0236*YAMATO  0088*FG 0092*FG  0201080043* 367*YAMATO           0153*FGYAMATO 0158*FGYAMATO  0202100005* 0202100008*  610*YAMATO      701*TTL  0093*FG 0159*FGYAMATO 292*YAMATO 287*YAMATO     0240*YAMATO     0201090001* 98*FG 580*YAMATO 101*FG  0099*FG 472*YAMATO 471*YAMATO 375*YAMATO 0202090027* 290*YAMATO  0105*FG 0103*FG 0104*FG 0162*FGYAMATO    869*YAMATO 0165*FGYAMATO  0164*FGYAMATO 0163*FGYAMATO 0169*FGYAMATO 0166*FGYAMATO 380*YAMATO   0238*FG 0237*FG 293*YAMATO 295*YAMATO  773*YAMATO 0202090025* 106*FG 778*YAMATO 871*YAMATO 0175*FGYAMATO  382*YAMATO 375*FG 384*YAMATO 474*YAMATO 0201080067* 0241*YAMATO 294*YAMATO 296*YAMATO 298*YAMATO 634*YAMATO    0109*FG 0108*FG 381*YAMATO 385*YAMATO 389*YAMATO  0110*FG 0202100040* 0202100041* 0202100053* 0189*FGYAMATO 0170*FGYAMATO   303*YAMATO 300*YAMATO 0111*FG 987* 0202080006* 0202080008*    635*YAMATO    112*FG 0167*FGYAMATO 0184*FGYAMATO 0201070005* 0202080012* 0201080060*   0201080058*  0201080059*  0201070004* 0201080068* 305*YAMATO 302*YAMATO 390*YAMATO 872*YAMATO 0243*YAMATO 0107*FG 0202100003* 0202100009* 0202100011*  392*YAMATO 313*YAMATO  308*YAMATO 0202080010* 190*YAMATO 306*YAMATO 0113*FG     0115*FG 491*TTL 489*TTL   498*YAMATO  0116*FG  247*FG  500*YAMATO 0202100010* 0117*FG  0171*FGYAMATO  0118*FG  0202100015* 0202100016* 0202100012*  123*TTL    0202090026* 0172*FGYAMATO  408*YAMATO 0231*YAMATO  301*YAMATO 309*YAMATO   0201080002* 125*FG 122*FG  124*FG    396*F08A 414*YAMATO 407*YAMATO 415*YAMATO 410*YAMATO   0201070003* 0202080002* 0202080006* 181*FG 191*FG 320*YAMATO 321*YAMATO  0202100017* 0202100018* 0202100022* 0250*YAMATO  0201090002* 322*YAMATO  873*YAMATO 0127*FG  0253*YAMATO 0129*FG 513*YAMATO   668*YAMATO 0182*FGYAMATO 0176*FGYAMATO 834*YAMATO 324*YAMATO  327*YAMATO  0201080049* 0201080050* 0201080071* 0251*YAMATO 0256*YAMATO 128*FG 0179*FGYAMATO 0257*YAMATO  669*YAMATO 0202100058* 0202100059* 0202100057* 132*FG  636*YAMATO 0202090028* 0202100023*  0202080015* 0201070004* 00249*YAMATO 0202080001* 0185*FGYAMATO 0180*FGYAMATO 0121*FG 681*YAMATO 0202080020* 0202080021* 0202080022*   328*YAMATO  0201090003* 0202080019* 0202100019* 0202100024* 0202100025* 0202100029* 0202100031* 0186*FGYAMATO    0187*FGYAMATO   671*YAMATO   774*YAMATO 837*YAMATO 411*YAMATO   0244*TTL 0202080016*  438*YAMATO 
Recalling Firm/
Advanced Sterilization Products
33 Technology Dr
Irvine CA 92618-2346
For Additional Information Contact
Manufacturer Reason
for Recall
Advanced Sterilization Products (ASP) is recalling the STERRAD 200 Sterilization System because it may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
FDA Determined
Cause 2
Under Investigation by firm
Action A customer notification letter was sent on September 18, 2013, to all customers who received the STERRAD 200 Sterilization System. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to indicate if they have received a STERRAD 200 System and to report any complaints or suspected problems to Advanced Sterilization Products (ASP) Professional Services directly at (888) 783-7723 and select option #2. An alternate design for the oil mist filter is being developed and qualification of new vacuum pump oil is in process. This action is to modify the PM interval to service the filter and oil more frequently. This will serve as an immediate/interim solution to reduce incidence of odor/smell complaints until the new oil mist filter design and vacuum pump oil are released. A Customer Letter will be sent to all STERRAD 200 customers to notify them of the issue and the corrective actions we are taking to resolve this issue.
Quantity in Commerce 1,305 units total (654 units in US , 651 OUS )
Distribution Worldwide Distribution - USA (nationwide) and the countries of EA (Europe Middle East and Asia), APAC (Asia Pacific), Japan and Canada
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MLR and Original Applicant = ADVANCED STERILIZATION PRODUCTS