Events

Device Recall Safety PICC Insertion Tray with Chloraprep OneStep 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Custom Healthcare Systems, 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
    69762
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2096-2015
  • 사례 시작날짜
    2014-11-05
  • 사례 출판 날짜
    2015-07-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-01-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132569
  • 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
    Needle, catheter - Product Code GCB
  • 원인
    An incorrect item number is packed within the outside "piggybacked" package. the interior sealed sterile kit is correct and no adverse issues affect that part of the item. the non-sterile outside "piggybacked" package mistakenly contains item #8881579121 - syringe prefilled, saline flush, 09% sodium chloride and is a nonsterile product that cannot be dropped into the sterile field.
  • 조치
    Custom Healthcare System sent an Urgent Product Recall letter dated November 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. PLEASE CHECK YOUR INVENTORY AND QUARANTINE ANY AFFECTED PRODUCT MATCHING THE DESCRIPTIONS ABOVE. Call 804 (421-5959) with regards to returning the affected products. Return Authorizations will be issued and product pickup and return will be scheduled.

Device

Device Recall Safety PICC Insertion Tray with Chloraprep OneStep
  • 모델명 / 제조번호(시리얼번호)
    Lot#92414 Exp Date 11/1/15, Lot#100214 Exp Date 11/1/15 Lot#100914 Exp Date 11/1/15
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution to CT.
  • 제품 설명
    Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
  • Manufacturer
    Custom Healthcare Systems, Inc.

Manufacturer

Custom Healthcare Systems, Inc.
  • 제조사 주소
    Custom Healthcare Systems, Inc., 4205 Eubank Rd, Richmond VA 23231-4328
  • 제조사 모회사 (2017)
    Custom Healthcare Systems Inc.
  • Source
    USFDA