Events

Device Recall Baxter Spinal Anesthesia Trays 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Healthcare Corp. 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
    31491
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0800-05
  • 사례 시작날짜
    2005-03-28
  • 사례 출판 날짜
    2005-05-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-03-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37982
  • 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
    The anesthesia trays contain bd 25g spinal needles which which have leakage at the plastic hub of the needle.
  • 조치
    Urgent Device Correction letters dated 3/28/05 were sent to the direct accounts via first class mail. The accounts were informed of the leakage associated with the plastic hub of the spinal needle contained in the trays, and were provided with a listing of product codes and lots numbers of the spinal trays affected. The accounts were instructed to check their inventory for the affected trays and to contact BD at 1-888-237-2762 for instructions on how to obtain replacement spinal needles. Replacement needles will be shipped overnight, and the accounts were instructed to remove and destroy the needle in the tray and replace it with the replacement needles when the tray is opened prior to the procedure.

Device

Device Recall Baxter Spinal Anesthesia Trays
  • 모델명 / 제조번호(시리얼번호)
    product code 1T2156, lots GD809251, GD809582; product code 1T2352, lot GD810325; product code 1T2356, lots GD809152, GD810333;  product code 1T2450, lot GD809590;  product code 1T2451, lot GD801282;  product code 1T2456, lots GD810564, GD808519, GD800516, GD804492, GD805960, GD812024, GD810861, GD806323, GD810366, GD806620;  product code 1T7457, lots GD810911, GD809624; product code 2T0086, lot 809335;  product code 2T0188, lot GD812255; product code 2T0298, lot GD809632;  product code 2T0310, lot GD809640; product code 2T0329, lot GD809657; product code 2T0341, lot GD808642; product code 2T0378, lot GD809673; product code 2T0455, lots GD810614, GD809699;  product code 2T0458, lot GD811448;  product code 2T0555, lots GD810622, GD809400;  product code 2T0618, lot GD811182;  product code 2T0642, lots GD810655, GD808931;  product code 2T0643, lot GD811455;  product code 2T0661, lots GD808956, GD809434;  product code 2T0770, lot GD810275;  product code 2T0783, lot GD810101;  product code 2T0784, lot GD809830;  product code 2T2001, lot GD810788;  product code 2T2007, lots GD810416, GD812156;  product code 2T2008, lot GD809467;  product code 2T2011, lot GD811737; product code 2T2014, lots GD809475, GD811026;  product code 2T2022, lot GD808683; product code 2T2023, lot GD808311; product code 2T2025, lots GD811471, GD810127;  product code 2T2108,lot GD809004; product code 2T2226, lot GD810721; product code 2T2230, lots GD811059, GD808360;  product code 2T2287, lot GD809491; product code 2T2342, lots GD811117, GD808410
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Puerto Rico, Amaerical Samoa, Guam, Canada and Venezuela
  • 제품 설명
    Baxter Spinal Anesthesia Trays; sterile, single use only procedure trays that contain BD 25G x 8.9 cm (3-1/2'') Whitacre Spinal Needles; Assembled by Baxter Healthcare Corporation, Deerfield, IL 60015
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • 제조사 주소
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA