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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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Product Detail

Product Description 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.
Recall Number Z-0043-2014
Classification Class II
Code Info 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
Product Distributed Qty 1,305 units total (654 units in US , 651 OUS )
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.

Event Detail

Event Id 66328
Product Type Devices
Status Ongoing
Recalling Firm Advanced Sterilization Products
City Irvine
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and the countries of EA (Europe Middle East and Asia), APAC (Asia Pacific), Japan and Canada