Events

Blanketrol III, Model Number 233 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cincinnati Sub-Zero Products Inc 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
    66155
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2209-2013
  • 사례 시작날짜
    2013-09-03
  • 사례 출판 날짜
    2013-09-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-08-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121580
  • 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
    System, thermal regulating - Product Code DWJ
  • 원인
    During a label review it was discovered that both the blanketrol iii operations (57201-n) & operations & technical (56201-q) manuals had verbiage added back into the manual during ecn m111-4260 (released 12/29/2011) which was previously removed for clarification of the intended use and subsequent 501(k) approval.
  • 조치
    Cincinnati Sub-Zero (CSZ) sent an Urgent Medical Device Field Action letter dated September 5, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact CSZ at 513-772-8810 or 1-800-989-7373 to request new versions of the manuals. At that time customers are instructed to provide the quantity and serial numbers of the affected devices that are at their facility. Upon receipt of the new versions of the manual, immediately collect and destroy/discard all the affectred devices Operation and Technical Manuals their facility is currentlyin possession of and replace the discarded manuals with the new versions of the manuals provided by CSZ. After the manuals have been discarded and replaced, customers were asked to complete and return the enclosed response form as soon as possible to acknowledge receipt of this notification and to inform CSZ that they have performed and completed the requested actions. Customers should return the form by fax to 513-772-9119 scan and email the information to B3manual@cszinc.com or mail to Cincinnati Sub-Zero, 12011 Mosteller Road, Cincinnati, Ohio 45241. Customers with questions were instructed to contact their Blanketrol III Model 233 field action coordinator at 1-800-989-7373 or 513-772-8810. For questions regarding this recall call 513-772-8810, ext 5295.

Device

Blanketrol III, Model Number 233
  • 모델명 / 제조번호(시리얼번호)
    Part number: 86107/06107/6107 (115V), Serial #s: 112-3-02021, 112-3-02102 through 124-3-02783, 074-3-00388, 081-3-00489, 081-3-00493, 082-3-00511, 091-3-00935, 094-3-01261, 094-3-01265, 094-3-01272, 094-3-01304, 094-3-01308, 101-3-01384, 093-3-01045, 093-3-01046, 093-3-01069, 084-3-00775, 073-3-00315, 091-3-00918, 091-3-00919, 073-3-00279, 094-3-01262, 071-3-00183, 092-3-00983, 094-3-01255, 064-3-00114, 072-3-00219, 072-3-00222, 072-3-00230, 072-3-00258, 081-3-00499, 081-3-00500, 064-3-00116, 064-3-00117, 092-3-01021, 073-3-00305, 073-3-00314, 082-3-22572, 082-3-22573, 101-3-01380, 073-3-00317, 074-3-00341, 091-3-00932, 094-3-01310, 101-3-01374, 082-3-00559, 092-3-00983, 094-3-01255, 094-3-01305, 062-3-00029, 093-3-01048, 094-3-01240, 102-3-01504 & 094-3-01243.  Part number: 86207/6207 (230V) Serial #s: 112-3-01949, 114-3-02171 through 124-3-02764, 072-3-00247, 073-3-00266, 073-3-00282, 082-3-00564, 071-3-00132, 071-3-00152, 073-3-00309, 082-3-00533, 082-3-00534, 082-3-00565, 082-3-00568, 084-3-00768, 084-3-00770, 084-3-00777, 084-3-00778, 084-3-00779, 084-3-00780, 084-3-00781, 084-3-00787, 084-3-00788, 091-3-00836, 091-3-00877, 091-3-00878, 091-3-00902, 092-3-01007, 092-3-01008, 092-3-01011, 102-3-01423, 102-3-01426, 103-3-01592, 103-3-01593, 103-3-01594, 103-3-01595, 103-3-01601, 093-3-01072, 093-3-01073, 093-3-01076, 093-3-01078, 093-3-01084, 093-3-01085, 093-3-01086, 093-3-01087, 093-3-01088, 093-3-01104, 093-3-01105, 093-3-01106, 093-3-01107, 093-3-01108, 103-3-01573, 103-3-01574, 103-3-01575, 071-3-00178, 071-3-00180, 074-3-00393, 074-3-00394, 074-3-00395, 074-3-00396, 074-3-00404, 074-3-00405, 091-3-00904, 091-3-00905, 092-3-00939, 092-3-00948, 092-3-00949, 092-3-00951, 092-3-00962, 092-3-00963, 094-3-01178,094-3-01179, 094-3-01180, 094-3-01181, 094-3-01183, 084-3-00789, 084-3-00790, 084-3-00791, 084-3-00812, 084-3-00813, 084-3-00814, 084-3-00815 & 084-3-00816.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AK, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MT, , NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI & WV. Internationally to ARGENTINA, AUSTRALIA, AZERBAIJAN, BELGIUM, CANADA, CHILE, CHINA, COSTA RICA, CROATIA, GERMANY, HONDURAS, HONG KONG, INDIA, INDONESIA, ISRAEL, KOREA, KUWAIT, MEXICO, NEW ZEALAND, PERU, SAUDI ARABIA, SINGAPORE, SPAIN, TAHITI, THAILAND, THE NETHERLANDS, THE PHILIPPINES, UNITED ARAB EMERITES & UNITED KINGDOM.
  • 제품 설명
    Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 || Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.
  • Manufacturer
    Cincinnati Sub-Zero Products Inc

Manufacturer

Cincinnati Sub-Zero Products Inc
  • 제조사 주소
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241-1528
  • 제조사 모회사 (2017)
    Gentherm, Inc.
  • Source
    USFDA