FDAFDA · Food and drugs·Recall number Z-0043-2014
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.
Published October 30, 2013 · Recall initiated: September 18, 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
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Advanced Sterilization Products
- Distributor
- Worldwide Distribution - USA (nationwide) and the countries of EA (Europe Middle East and Asia), APAC (Asia Pacific), Japan and Canada
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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