LIifeShield CLAVE 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hospira Inc. 에 의해 제조된 제품과 관련되어 있습니다.

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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.

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  • 사례 유형
    Recall
  • 사례 ID
    66372
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2058-2016
  • 사례 시작날짜
    2013-09-09
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-12-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • 데이터 추가 비고
    Set, administration, intravascular - Product Code FPA
  • 원인
    Intravenous fluid may leak at the clave secondary port of hospira plumset iv administration sets.
  • 조치
    Hospira sent an URGENT MEDICAL DEVICE CORECTION letters dated September 9, 2013 to customers. The letter identified the affected product, problem and actions to be taken. the letter included additional instructions on the proper handling/use of the CLAVE devices. The letters request that all incidents of separation or breakage of CLAVE from the secondary port of the cassette be reported to Hospira by calling 1-800-441-410 (Monday - Friday, 8:00 AM - 5:00 PM CST) or by e-mail at ProductComplaintPP@hospira.com. Customers are further requested to complete and return a response form included wih the URGENT MEDICAL DEVICE CORRECTION letter and to notify any customers of this advisory. Hospira will also be supplementing the instructions for CLAVE use as an interim measure until a new method for bonding the CLAVE to the secondary port of the Plum cassettes can be devised and implemented.

Device

  • 모델명 / 제조번호(시리얼번호)
    ***** US DISTRIBUTION *****   *** 1) List Number: 14212-04-28; Lot Numbers:  962235H , 030565H , 030575H , 081425H , 090515H , 100905H , 100915H , 102255H , 102265H , 122515H , 122525H , 143405H , 152655H , 152665H , 152675H , 161375H , 161385H , 161395H , 170955H , 172025H , 172035H , 172045H , 143415H , 241805H , 251735H , 251745H , 250845H ;  *** 2) List Number: 14254-08-28; Lot Number:  072055H;  *** 3) List Number: 14687-04-28; Lot Numbers:  650935H , 710435H , 720925H , 721925H , 721895H , 721325H , 721905H , 730175H , 761965H , 771895H , 772175H , 780725H , 781395H , 780715H , 800135H , 800145H , 810185H , 851685H , 840795H , 861775H , 861785H , 810155H , 880695H , 901065H , 901055H , 901095H , 921945H , 020765H , 020775H , 020785H , 020795H , 030185H , 030195H , 042005H , 052335H , 052755H , 052345H , 061035H , 070625H , 080325H , 080335H , 091085H , 092935H , 132125H , 142805H , 153285H , 153495H , 171435H , 180405H , 211275H , 201225H , 201235H ;    ***** FOREIGN DISTRIBUTION *****   *** 4) List Number: 12193-83-24; Lot Numbers:  662095H , 712345H , 741615H , 880705H , 890735H , 920595H , 952665H , 020485H ;  *** 5) List Number: 12193-92-28; Lot Numbers:  063285H , 071115H , 071475H , 133335H , 140205H , 171535H , 180045H , 250515H , 281895H ;  *** 6) List Number: 19194-83-24; Lot Numbers:  662115H , 702305H , 721795H , 721805H , 732055H , 732035H , 732045H , 732065H ;  *** 7) List Number: 19194-84-24; Lot Numbers:  881945H,  950975H;  *** 8) List Number: 12194-92-28; Lot Numbers:  071105H , 140085H , 151445H , 180055H ;  *** 9) List Number: 12195-83-24; Lot Numbers:  662105H , 712355H , 821545H , 880715H , 890745H , 910745H ;  *** 10) List Number: 12195-84-24; Lot Numbers:  681645H , 681655H , 702295H , 721695H , 721785H , 741635H , 741355H , 761495H , 771395H , 782265H , 782275H , 791315H , 890755H , 900455H , 940615H , 951325H , 010725H , 011475H , 020895H , 021415H ;  *** 11) List Number: 12195-92-28; Lot Numbers:  063185H , 063195H , 071125H , 102395H , 102405H , 111705H , 111715H , 113055H , 112865H , 131865H , 133405H , 140115H , 153385H , 162385H , 171445H , 180065H , 180075H , 200855H , 210865H , 201895H , 221315H , 250525H , 260235H , 271645H , 270825H ;  *** 12) List Number: 12196-83-24; Lot Numbers:  662125H , 702315H , 702325H , 712245H , 712255H ;  *** 13) List Number: 12196-84-24; Lot Number:  871295H;  *** 14) List Number: 12196-92-28; Lot Numbers:  071135H , 131835H , 151545H , 211645H , 250505H , 281575H ;  *** 15) List Number: 14001-07-28; Lot Numbers:  810195H , 810205H , 831395H , 830775H , 890985H , 902085H , 220125H ;  *** 16) List Number: 14001-82-28; Lot Numbers:  890945H , 932935H , 151585H ;  *** 17) List Number: 14001-83-28; Lot Numbers:  752235H , 851525H , 871535H , 890765H , 900465H , 910215H , 951335H , 960405H , 010735H , 010755H , 020905H , 032185H , 040965H , 053775H , 061775H ;  *** 18) List Number: 14001-84-28; Lot Numbers:  752254H , 830785H , 851515H , 890775H , 950355H ;  *** 19) List Number: 14001-92-28; Lot Numbers:  063255H , 081605H , 081615H , 091115H , 161615H , 162365H , 180395H , 190925H , 220155H , 190935H , 190945H ;  *** 20) List Number: 14007-82-01; Lot Numbers:  811595H,  160345H;  *** 21) List Number: 14007-92-28; Lot Numbers:  251485H,  270875H;  *** 22) List Number: 14009-82-01; Lot Numbers:  811525H,  840885H,  910095H;  *** 23) List Number: 14011-82-01; Lot Number:  811555H;  *** 24) List Number: 14012-92-28; Lot Numbers:  162315H,  231615H;  *** 25) List Number: 14013-82-01; Lot Numbers:  811535H,  840895H,  920855H;  *** 26) List Number: 14014-92-28; Lot Number:  162305H;  *** 27) List Number: 14015-82-01; Lot Numbers:  811515H,  910105H;  *** 28) List Number: 14017-82-01; Lot Number:  811705H;  *** 29) List Number: 14017-92-28; Lot Numbers:  112855H,  200955H;  *** 30) List Number: 14022-92-28; Lot Numbers:  162325H,  172265H;  *** 31) List Number: 14212-92-28; Lot Numbers:  071955H , 091685H , 100885H , 110505H , 113655H , 143425H , 161415H ;  *** 32) List Number: 19673-53-24; Lot Numbers:  662035H , 701715H , 721575H , 910115H , 910515H , 961555H , 011455H , 031335H , 061995H , 102145H , 111615H , 132705H , 180615H , 201815H , 220725H , 200275H , 241365H
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US (Nationwide) Distribution
  • 제품 설명
    *** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; *** 2) Product labeled in part: List No. 14254-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port 2 CLAVE Y-Sites, 0.2 Micron Filter, 112 Inch, Non-DEHP; || *** 3) Product labeled in part: List No. 14687-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port, CLAVE Y-Site; 103 Inch, Non-DEHP; || Product Usage: || The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • 제조사 모회사 (2017)
  • Source
    USFDA