The STERRAD Sterilization System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Advanced Sterilization Products 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    66328
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0043-2014
  • 사례 시작날짜
    2013-09-18
  • 사례 출판 날짜
    2013-10-22
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-04-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Sterilizer Chemical - Product Code MLR
  • 원인
    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.
  • 조치
    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.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot 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O 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
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of EA (Europe Middle East and Asia), APAC (Asia Pacific), Japan and Canada
  • 제품 설명
    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.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Advanced Sterilization Products, 33 Technology Dr, Irvine CA 92618-2346
  • 제조사 모회사 (2017)
  • Source
    USFDA