Events

ARTERIAL CATHETERIZATION KIT 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Arrow International 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
    57287
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1358-2011
  • 사례 시작날짜
    2010-10-29
  • 사례 출판 날짜
    2011-02-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95801
  • 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
    Wire, guide, catheter - Product Code DQX
  • 원인
    Sterility may be compromised.
  • 조치
    Arrow International, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated October 29, 2010, to all affected customers. The letter identified the products, the problem, and the action to be taken by the customer. Customers were instructed to quarantine the product. If they had no affected product in stock, check the appropriate box on the Recall Acknowledgement & Stock Status Form and fax the form to Arrow's Customer Service fax number 800-343-2935. If they had affected stock, immediately quarantine the product and contact Arrow Customer Service at 800-523-8446 for a Return Authorization Number. If customers wished to return product for replacement, they were to consult their sales representative or Arrow Customer Service for information on product availability, substitutability, and lead times. Complete the enclosed Recall Acknowledgement & Stock Status Form and immediately fax the compoleted form to Arrow, Fax number 800-343-2935, Attn: Customer Service. Return any affected product freight collect, along with the original completed Recall Acknowledgement & Stock Status Form to: Arrow International, Inc. 312 Commerce Place Aheboro, NC 27203 Attn: Asheboro Quality Assurance Manager. For any questions regarding this recall call 800-523-8446.

Device

ARTERIAL CATHETERIZATION KIT
  • 모델명 / 제조번호(시리얼번호)
    CC-04100 Lot Numbers: RF0019630, RF0035146, RF0062164, RF0063964, RF4121260, RF5012171, RF5022620, RF5022694, RF5022936, RF5023056, RF5043795, RF5044244, RF5054841, RF5060136, RF5072938, RF5083080, RF5084506, RF5095700, RF5106236, RF5118583, RF6012260, RF6022847, RF6033756, RF6034434, RF6035286, RF6057003, RF6068210, RF6070336, RF6080902, RF6081546, RF6093300, RF6104481, RF6115675, RF6116613, RF6127345, RF6127983, RF7018330, RF7020221, RF7032233, RF7054012, RF7054686, RF7065398, RF7076855, RF7077581, RF7088648, RF7089293, RF7090478, RF7101417, RF7112432, RF7113766, RF7124960, RF8015963, RF8020094, RF8029171, RF8031984, RF8033220, RF8044241, RF8045487, RF8056874, RF8057384, RF8068362, RF8071384, RF8083492, RF8085126, RF8096691, RF8109018, RF8110511, RF8110923, RF8123490, RF9015797, RF9027384, RF9028781, RF9030798, RF9044347, RF9056860, RF9057865, RF9060300, RF9071990, RF9101135, RF9112313, RF9112770, RF9114303 and RF9125231.  FS-04510 Lot Numbers: RF0020943, RF0033155, RF0059261, RF0062162, RF0075661, RF8033219, RF8045501, RF8070634, RF8119793, RF8124055, RF9030633, RF9068315, RF9071039, RF9085981, RF9101233 and RF9126921.  NS-04100 Lot Numbers: RF0021271, RF0035169, RF0059455, RF0062166, RF0076519, RF0087520, RF5012173, RF5012263, RF5022525, RF5022640, RF5022884, RF5033202, RF5043960, RF5044137, RF5044415, RF5054655, RF5055028, RF5060314, RF5072320, RF5084106, RF5095841, RF5106237, RF5107230, RF5118615, RF6011424, RF6012258, RF6022392, RF6033757, RF6034356, RF6045750, RF6057353, RF6057883, RF6068372, RF6068635, RF6070561, RF6079358, RF6080954, RF6081473, RF6082032, RF6093231, RF6104147, RF6116038, RF6116779, RF7018345, RF7020079, RF7029684, RF7031136, RF7031694, RF7042757, RF7043349, RF7054836, RF7066014, RF7066675, RF7077586, RF7088649, RF7089181, RF7090486, RF7101953, RF7102163, RF8015969, RF8016893, RF8029175, RF8031766, RF8033221, RF8044245, RF8045307, RF8057233, RF8068375, RF8072081, RF8083722, RF8097203, RF8107887, RF8111833, RF811833, RF9014775, RF9027307, RF9042699, RF9068374, RF9085995, RF9101133, RF9112853, RF9114302 and RF9125236.  PW-04100 Lot Numbers: RF8029429, RF8031774, RF8043868 and RF8057234.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States - all 50 States, and the countries of Canada, South America, China, South Africa, Australia, Puerto Rico, Philippines, Singapore, South Korea, New Zealand, Mexico, Japan, India, Indonesia, Bahamas, Taiwan, Thailand, Finland, France, Cyprus, Czech Republic, Belgium, Germany, Ireland, Italy, Latvia, Netherlands, Poland, Slovakia, Spain, Bahamas, Costa Rico, Dominican Republic, Ecuador, Guatamala and the United Kingdom.
  • 제품 설명
    ARTERIAL CATHETERIZATION KIT/Product SKU's (Codes) CC-04100, FS-04510, NS-04100 and PW-04100. || Cardiovascular catheterization kit
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • 제조사 주소
    Arrow International Inc, 2400 Bernville Road, Reading PA 19605
  • 제조사 모회사 (2017)
    Teleflex Incorporated
  • Source
    USFDA