Events

Device Recall Haemonetics 2380 MINI HandHeld Tube Sealer Power Source 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Haemonetics Corporation 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
    57855
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1899-2011
  • 사례 시작날짜
    2011-01-31
  • 사례 출판 날짜
    2011-04-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97588
  • 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
    Device, Heat-Sealing - Product Code KSD
  • 원인
    Battery pack may have exposed wire becoming hot.
  • 조치
    The firm, Haemonetics, issued a "Field Notification: 2380 Sealer battery pack" letter dated January 28, 2011 to its customers. An international English version of this letter (CL101020-IE) has been released to foreign Distribution countries. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) Record the manufacturing date of battery, equipment model, serial number, and photo of the affected battery. 2) Report the defect through the Haemonetics PIR system by emailing: sebra2380@haemonetics.com with all of the information listed including the appropriate contact information for their company. 3) Recycle or dispose of the nickel-cadmium (NiCad) battery pack in accordance with the local, state, federal, or country specific regulations. Under no circumstances should the battery pack be incinerated as this can cause explosion and personal injury. The operation manual will be updated to provide additional information about the proper installation and removal of the battery. This updated manual will be distributed with new devices upon release. Should you have any questions or concerns regarding this matter, please contact the firm at sebra2380@haemonetics.com.

Device

Device Recall Haemonetics 2380 MINI HandHeld Tube Sealer Power Source
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA and countries including: Australia, Austria, AEU, Belgium, Bangladesh, Canada, China, France, Germany, Hong Kong, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, New Zealand, Pakistan, Philippines, Singapore, Sri Lanka, Taiwan and Turkey.
  • 제품 설명
    2380 MINI Hand-Held Tube Sealer Power Source || (including a 23802000 Battery Pack) || The Model 2380 Power Source is an instrument that generates RF power for making seals on tubing made of RF reactive thermoplastic materials typically used in blood banks, blood processing facilities and transfusion centers.
  • Manufacturer
    Haemonetics Corporation

Manufacturer

Haemonetics Corporation
  • 제조사 주소
    Haemonetics Corporation, 400 Wood Rd, Braintree MA 02184-2412
  • 제조사 모회사 (2017)
    Haemonetics Corporation
  • Source
    USFDA