Events

Tape Fog Shield Surgical Mask Green Fiberglass Free 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Precept Medical Products, 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
    45435
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0153-2008
  • 사례 시작날짜
    2007-09-14
  • 사례 출판 날짜
    2007-12-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-09-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65466
  • 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
    Surgical Mask - Product Code FYA
  • 원인
    Small slits under the folds of the masks; thus they may not provide the protection necessary between the patient and surgical staff.
  • 조치
    The firm notified its consignees on 09/14/2007 by Urgent Voluntary Medical Device Recall letter (USPS mail, certified, return-receipt requested). The recall was expanded on 10/04/2007 by Urgent Voluntary Medical Device Recall--Expansion Letter to include additional lots of product. Recall letters instruct users to cease use of devices and return them as well as conduct sub-recalls to the users level for any devices they have sub-distributed.

Device

Tape Fog Shield Surgical Mask Green Fiberglass Free
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 1053430 through 1061090, and 1060180, 1060190, 1060200, 1060230, 1060240, 1060250, 1060260, 1060270, 1060300, 1060310, 1060320, 1060440, 1060450, 1060460, 1060470, 1060480, 1060510, 1060520, 1060530, 1060660, 1060670, 1060680, 1060970, 1061000, 1061240, 1061250, 1061350, 1061360, 1061370, 1061390, 1061420, 1061440, 1061450, 1061530, 1061560, 1061570, 1061580, 1061590, 1061630, 1061640, 1061650, 1061670, 1061710, 1071720, 1061730, 1061790, 1061800, 1061810, 1061840, 1061850, 1061860, 1061870, 1062010, 1062020, 1062060, 1062070, 1062090, 1062120, 1062130, 1062190, 1062200, 1062210, 1062220, 1062360, 1062370, 1062390, 1062400, 1062440, 1062470, 1062510, 1062540, 1062560, 1062570, 1062580, 1062690, 1062700, 1062710, 1062720, 1062760, 1062770, 1062780, 1062790, 1062820, 1062850, 1062860, 1062890, 1062900, 1062910, 1062970, 1062980, 1063030, 1063040, 1063050, 1063060, 1063180, 1063190, 1063200, 1063260, 1063270, 1063280, 1063290, 1063330, 1063390, 1063400, 1063410, 1063420, 1063430, 1063450, 1063460, 1063470, 1063480, 1063500, 1070080, 1070090, 1070110, 1070120, 1070290, 1070300, 1070310, 1070320, 1070460, 1070470, 1070500, 1070510, 1070520, 1070530, 1070540, 1070600, 1070640, 1070650, 1070660, 1070850, 1070860, 1070870, 1070880, 1071000, 1071310, 1071430, 1071440, 1071450, 1071460, 1071480, 1071490, 1071500, 1071510, 1071520, 1071530, 1071550, 1071620, 1071650, 1071660, 1071670, 1071690, 1071700, 1071710, 1071720, 1071730, 1071740, 1071760, 1071770, 1071780, 1071790, 1071810, 1071830, 1071840, 1071850, 1071860, 1071870, 1071880, 1071900, 1071920, 1071930, 1071940, 1071950, 1071970, 1071980, 1071990, 1072000, 1072050, 1072060, 1072070, 1072080, 1072110, 1072120, 1072130, 1072180, 1072190, 1072200, 1072230, 1072250, 1072260, 1072350, 1072400, 1072410, 1072420, 1072460, 1072470, 1072480, 1072490, 1072500, 1072530, 1072540, 1072550, 1072560, and 1072570,  and Lot Numbers 1062207 through 1071147 (only those lots in this range with the last digit of "7" (seven))
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide; USA, Australia and Canada
  • 제품 설명
    Precept Medical Products, Tape Fog Shield Surgical Mask Green Fiberglass Free, REORDER #: 65-3322, non-sterile, 50/box, 5 box/case, Precept Medical Products, Inc., Arden, NC 28704, 1-800-438-5827, Mexico
  • Manufacturer
    Precept Medical Products, Inc.

Manufacturer

Precept Medical Products, Inc.
  • 제조사 주소
    Precept Medical Products, Inc., 370 Airport Rd, Arden NC 28704-9202
  • Source
    USFDA