Events

Device Recall STERRAD Cyclesure Biological Indicator (BI), 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
    33854
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2100-2012
  • 사례 시작날짜
    2012-06-28
  • 사례 출판 날짜
    2012-07-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-08-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110734
  • 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
    Indicator, biological sterilization process - Product Code FRC
  • 원인
    Advanced sterilization products (asp) is recalling certain lots of the sterrad cyclesure 24 biological indicator (bi) product because it does not have adequate data to support the entire duration of the product's labeled shelf-life.
  • 조치
    ASP has posted the STERRAD CYCLESURE Biological Indicator customer letter on their external facing website at: wwww.aspjj.com/us/news/cyclesureletter on July 3, 2012. The letter informed customers who purchased STERRAD CYCLESURE 24 Biological Indicator (BI) product that Advanced Sterilization Products (ASP) is recalling certain lots because ASP has determined that it does not have adequate data to support the entire duration of the product's labeled shelf-life. The letter also provided the customers with what actions are needed for the recall. Customers were instructed to return all unused STERRAD CYCLESURE 24 BI product that exceeds the newly determined expiration dated using the enclosed prepaid UPS return label to Stericycle, 2670 Executive Drive Suite A, Indiapolis, IN 46241. Customers were instructed to count their inventory of product that exceeds the newly determined expiration date and record the data on the enclosed Business Reply Card and packing slip that are included with the customer recall letter. Customers were instructed to complete the requested information on the enclosed postage paid Business Reply Card and return it to Stericycle. Customers were instructed to contact Stericycle at (877) 907-7030 if they need additional packing labels. If customers further distribute the affected products to other locations, then they were instructed to contact Stericycle to arrange for return of the product. Customers were instructed that new shipments of STERRAD CYCLESURE 24 BI product will be shipped on July 9, 2012 that has accurate expiration dates that do not require conversion. Customers wil be able to differentiate between current product and the newly shipped product by the lot number. Current product has a lot number containing 6 characters, eg. 123456. Newly shipped product will have a lot number containing 8 characters, eg. 123456EE. Customers with any additional questions were instructed to contact (877) 907-7030 or contact their A

Device

Device Recall STERRAD Cyclesure Biological Indicator (BI),
  • 모델명 / 제조번호(시리얼번호)
    Lot# 002127, 003127, 005127, 006127, 007127, 008127, 009127, 010127, 011128, 012127, 013127, 014127, 015127, 016127, 018127, 019127, 020127, 021127, 023127, 024127, 025127, 026127, 027127, 028127, 030127, 031127, 032127, 033127, 034127, 035127, 036127, 037127, 038121, 038127 039127, 040127, 041121, 042127, 043127, 044127, 045121, 045127, 046127, 047127, 048127, 049127, 052127, 053121, 053127, 054127, 055121, 056127, 057127, 058127, 059127, 060127, 061127, 062121, 062127, 063127, 064127, 065127, 067127, 068127, 069121, 069127, 070127, 071127, 072127, 073127, 074127, 076121, 077127, 078127, 078128, 079127, 081127, 082127, 084127, 085127, 086121, 086127, 087127, 089127, 090127, 092127, 093121, 094127, 095127, 100121, 100127, 101127, 102127, 104127, 107121, 107127, 107128, 109127, 109128, 110127, 111127, 114121, 114127, 118127, 121121, 121127, 123127, 124127, 125127, 128121, 128127, 129127, 130127, 131127, 132127, 135121, 135127, 136127, 137127, 138127, 139127, 142121, 142127, 143127, 144127, 145127, 146127, 150121, 150127, 151127, 152127, 152128,156127, 157127, 158127, 159127, 160127, 163127, 164127,165127, 339117, 340117, 341117, 342117, 343117, 344117, 345117, 346117, 347117, 348117, 349117, 350117, 351117, 352117, 353117, 354117, 355117, 357117, 360117, 362117, 363117, 364117.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide)
  • 제품 설명
    STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. || The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

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