Events

Device Recall Reserve, Cassette, CADD, 100ml, mdl 2100, 21700224 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smiths Medical MD, 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
    38306
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1215-2007
  • 사례 시작날짜
    2007-06-18
  • 사례 출판 날짜
    2007-08-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-02-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53379
  • 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
    Medication Cassette Reservoir - Product Code FPA
  • 원인
    Smith medical has become aware that an increase in ph may occur with some medications when instilled in the affected cassettes. also, a small number of catheter occlusions have been reported from one customer when these cassettes have been used for delivering flolan.
  • 조치
    All customers who have received the CADD Medication Cassette reservoirs have been sent the Product Recall Notification Letter on June 18, 2007 making them aware of the potential issue. Customers will be required to return the affected devices to Smiths Medical. All returned recall affected product will be quarantined and then destroyed. The consignees are to fill and fax "Attachment 1" form in regard to affected product inventory to Smiths Medical MD.

Device

Device Recall Reserve, Cassette, CADD, 100ml, mdl 2100, 21700224
  • 모델명 / 제조번호(시리얼번호)
    081X16, 082X16, 085X16, 088X16, 089X16, 090X16, 091X16, 094X16, 095X16, 096X16, 097X16, 104X16, 105X16, 106X16, 107X16, 109X16, 110X16, 112X16, 113X16, 115X16, 119X16, 120X16, 121X16, 122X16, 123X16, 128X16, 129X16, 136X16, 138X16, 142X16, 144X16, 145X16, 149X16, 152X16, 154X16, 155X16, 157X16, 160X16, 161X16, 163X16, 164X16, 167X16, 168X16, 169X16, 170X16, 171X16, 172X16, 173X16, 176X16, 177X16, 179X16, 182X16, 183X16, 186X16, 187X16, 189X16, 190X16, 192X16, 195X16, 196X16, 199X16, 200X16, 203X16, 204X16, 206X16, 207X16, 209X16, 210X16, 211X16, 212X16, 213X16, 214X16, 216X16, 218X16, 220X16, 221X16, 222X16, 223X16, 228X16, 229X16
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Canada, Mexico, Sweden, Germany, Japan, Australia, Taiwan, Poland, Jordan, Czech Republic, Denmark, Paraguay, Hong Kong, Singapore, Argentina, Italy, Venezuela, Greece, Norway, Pakistan, Puerto Rico, Thailand, United Arab Emirates, Netherlands Antilles, Malaysia, Panama, Hungary, Saudi Arabia, Portugal, South Africa, Denmark, the Netherlands, France, United Kingdom, Great Britain, Spain, Finland, Guam, Virgin Islands, China, Israel, Austria, and Switzerland.
  • 제품 설명
    Smiths CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC || 4695-24A, REF 21-7002-24, Sterile EO, Made in Mexico Smith Medical MD, Inc. St Paul, MN 55112 USA
  • Manufacturer
    Smiths Medical MD, Inc.

Manufacturer

Smiths Medical MD, Inc.
  • 제조사 주소
    Smiths Medical MD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Source
    USFDA