Events

Device Recall BD Epilor Syringe 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Becton Dickinson & Company 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
    66070
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2274-2013
  • 사례 시작날짜
    2013-08-23
  • 사례 출판 날짜
    2013-09-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-03-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121436
  • 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
    Anesthesia conduction kit - Product Code CAZ
  • 원인
    Bd has received several reports indicating that the plunger of the 7 ml bd epilor plastic bd luer-lok loss of resistance syringe may stall or stick within the syringe preventing the user from detecting a loss of resistance upon entering the epidural space.
  • 조치
    BD sent a product advisory notice to distributors/customers dated August 23, 2013 via UPS 2nd day mail. Consignees will be contacted by phone email and letter. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to be aware of the issue with the product and to follow the standard routine procedure to ensure that there is no resistance in the syringe prior to use. Any syringe that shows sticking or stalling should be discarded. Customers who distributed this product, should identify their customers and notify them at once of the product advisory. Customers with questions were instructed to call BD Customers Service at 1-800-237-2762. For questions regarding this recall call 201-847-6800.

Device

Device Recall BD Epilor Syringe
  • 모델명 / 제조번호(시리얼번호)
    510K K925902 D041521  Catalog Number: 405198 Lots 8310086 9246684 0035495 0053165 0056608 0056607 0096757 0120074 0126127 0152581 0242475 0258468 0258469 0258472 0291220 0291221 0291223 0291224 0278495 0291218 0291219 0291222 0291226 0291227 0291228 0336391 0336393 0336396 0336400 1005321 1006136 1033177 1033178 1094304 1209634 1210646 1213990 1213993 1276782 1307383 2032802 2033712 2060835 2065940 2084318 2121011 2122467 2205098 2212313 2276066 3038272 3042376 3063436 3063440 3085498 3085001 3085003 3085005 3123462 3123246 3184092       Catalog Number 405291 Lots 0154661 0174905 0252565 0279140 0301813 0347866 1012200 1035046 1063738 1095340 1124755 1180073 1213029 1262268 1273795 1312116 1320204 1356378 2041210 2058524 2083246 2135469 2158092 2170207 2194139 2205106 2223162 2223337 2250088 2286395 2303137 2303141 2334338 2334339 2355389 2355391 3057376 3120039    Catalog Number 405807 Lots GD873422 GD874743 GD875419 GD876029 GD876912 GD879577 GD881128 GD883033    Catalog Number 405823 Lots GD877068 GD882951 GD884312 GD885491 GD886192 GD887893 GD889527 B01F223D B01F243D B01G057D B01G196D   Catalog Number 406078;  Lots GD876003 GD877787 GD881169 GD883017 GD883660 GD885202 GD886283 GD888677 GD890442 B01F054D B02F156D B02F178D B03F074D B03F241D     Catalog number 406084 Lots B03F090D B06F326D GD875369 GD880427 GD883025 GD888255 B05G087D     Catalog # 406119 Lots GD873364 GD875625 GD877878 GD879015 GD881813 GD885129 GD889782 B02F051D B02F096D B01F135D B03F222D  Catalog # 406121 Lots GD887596 GD889618    Catalog # 406156 Lots GD887778 GD889733 GD889980 GD890178 B02F214D B02F292D B02G157D B03F292D B03G158D B04F238D B05F241D
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including FL, VA, TX, NY, IL, AZ, MI, RI, NJ, SC, MO, TN, CA, MN, UT, GA, NE, OH, MD, PA, MT and internationally to Brazil, Australia, Canada, and Puerto Rico..
  • 제품 설명
    BD Epilor Syringe || BD Franklin Lakes, NJ 07417 || BD EDC Laagstraat 57, B-9140 Temse-Belgium || The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • 제조사 주소
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA