Events

Device Recall Gemini, Alaris 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardinal Health 303 Inc DBA Alaris 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
    38225
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1020-2007
  • 사례 시작날짜
    2007-06-18
  • 사례 출판 날짜
    2007-08-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53191
  • 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
    IV Administration Infusion Sets - Product Code FRN
  • 원인
    It has been determined that with low probability, over-infusion may occur as a result of an open safety clamp fitment (a.K.A. flo-stop fitment) on the pumping segment, whether opened intentionally in the course of expected clinical practice, or as a result of inadvertent action. the over-infusion occurrence is dependent on the user not closing the roller clamp first, as required by clinical practi.
  • 조치
    The field action will consist of a mailing and will be conducted through consignees (distributors) in the affected countries as well as direct customers for all IV Administration sets intended for use with Gemini Infusion Pumps and Alaris/Medley Pump modules. The customers and distributors will be notified by registered return receipt mail. For direct customers, separate letters will be sent to the Director of Nursing, Director of Materials and Director of Risk Management at each facility. Distributors will be sent multiple copies of the Safety Alert Notification and Tip Sheets; along with a cover letter outlining their responsibilities to complete the Safety Alert plan and notify their customers as requested. The domestic letters (direct customers and distributors) were mailed beginning on June 18, 2007 to all of the affected accounts via US Postal Service Certified Mail.

Device

Device Recall Gemini, Alaris
  • 모델명 / 제조번호(시리얼번호)
    The 173 models of the dedicated administration sets for use with Gemini Infusion Pumps and Alaris Pump module (a.k.a. Medley Pump module) affected by this issue are: 10010453, 10010454, 10010483, 10010541, 10010547, 10010761, 10010871, 10010916, 10011221, 10011301, 10011462, 10011652, 10012144, 10012182, 10012283, 10012293, 10012645, 10012802, 10013034, 10013037, 10013072, 10013186, 10013361, 10013373, 10013373, 10013374, 10013854, 10013889, 10013890, 10013923, 10014035, 10014855, 10015012, 10015048, 10015294, 10015312, 10015362, 10015364, 10015366, 10015366, 10015368, 10015370, 10015414, 10015489, 10015514, 10015645, 10015649, 10015861, 10015862, 10015896, 10031773, 10061661, 10062818, 10074281, 10108961, 10137405, 10142568, 10178573, 2110-0500, 2111-0500, 2120-0500, 2125-0500, 2126-0500, 2130-0500, 2131-0500, 2140-0600, 2141-0600, 2147-0600, 2177-0000, 2200-0006, 2200-0500, 2202-0500, 2203-0006, 2205-0000, 2210-0006, 2210-0500, 2211-0500, 2214-0001, 2214-0006, 2220-0006, 2220-0500, 2225-0500, 2226-0500, 2230-0500, 2231-0006, 2231-0500, 2240-0008, 2240-0600, 2241-0001, 2241-0006, 2241-0008, 2241-0600, 2247-0600, 2248-0600, 2255-0001, 2255-0500, 2260-0001,2260-0006, 2260-0008, 2260-0500, 2264-0006, 2264-0008, 2264-0500, 2277-0000, 2277-0006, 2277-0008, 2279-0006, 2280-0000, 2301-0500, 2377-0000, 2401-0006, 2401-0500, 2403-0000, 2403-0007, 2406-0500, 2410-0500, 2411-0500, 2412-0500, 2414-0006, 2420-0006, 2420-0007, 2420-0500, 2421-0500, 2425-0500, 2426-0500, 2430-0500, 2431-0500, 2440-0600, 2441-0007, 2441-0600, 2443-0600, 2447-0600, 2448-0600, 2449-0600, 2455-0500, 2464-0500, 2477-0000, 2477-0007, 2478-0000, 2904-0600, 2906-0000, 2906-0001, 2907-0000, 2907-0006, 2920-0000, 2929-0500, 2941-0500, 2942-0500, 2946-0600, 9943-0000, 9943-0001, 9943-0008, 9943T, 9943T-0008, 9950-0500, 9952-0500, 9953-0500, 9966-0006, 9971-0600, 9974-0600, C24101E, C24102M, C24103E, C24104E, C24105E, C24106E, C24107E, C24109E, C24111E, C24112, C24114E, C24116E, C24117, C24119E, C24120E
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide including USA, Argentina, Australia, Bahrain, Belgium, Canada, China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malta, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Qatar, Saudi Arabia, Serbia/Montenegro, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad &Tobago;, United Kingdom, United Arab Emirates, Uruguay & Venezuela.
  • 제품 설명
    All IV Administration Infusion Sets intended for use with the Gemini Infusion Pump and Alaris Pump module (a.k.a. Medley Pump module) including: Alaris SmartSite Low Sorbing Set, Alaris Vented Syringe Adapter Set, Alaris Burette Set, Cardinal Health SmartSite Infusion Set, Alaris Infusion Set, Alaris SmartSite Burette Set, Cardinal Health SmartSite Burette Set, Alaris SmartSite Administration Set, Alaris Infusion Burette Set, Alaris SmartSite Blood Set, Cardinal Health SmartSite Combination Infusion Set, Cardinal Health Blood Set, Alaris Medley/Gemini Infusion Set, Alaris Medley/Gemini Blood Set, Alaris Latex-Free Infusion Set, Alaris Light Sensitive Solution Set, Alaris Medley/Gemini Enteral Set, Imed Gemini 20 Vented/Nonvented Primary Administration Set, Imed Vented/Nonvented Gemini Prime-Saver Set, Imed Vented/Nonvented Gemini Short Set, Alaris Half Set, Cardinal Health Half Set, Alaris Latex-Free Burette Set, Alaris Opaque Set, Alaris Medley/Gemini Combination Infusion Set
  • Manufacturer
    Cardinal Health 303 Inc DBA Alaris Products

Manufacturer

Cardinal Health 303 Inc DBA Alaris Products
  • 제조사 주소
    Cardinal Health 303 Inc DBA Alaris Products, 10221 Wateridge Cir, San Diego CA 92121-2733
  • Source
    USFDA