Events

Device Recall Abbott LifeShield, Abbott Plumset, Abbott Soluset Pump Sets 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Laboratories HPD/ADD 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
    26450
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0958-03
  • 사례 시작날짜
    2003-06-09
  • 사례 출판 날짜
    2003-06-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-08-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27771
  • 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
    Pump, Infusion - Product Code FRN
  • 원인
    The drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
  • 조치
    The IV administration sets were recalled by letters dated 6/9/03, advising the accounts of the discoloration of the sight chamber and adapters due to the use of non-radiation grade plastic resin in the manufacture of these components of the sets and requesting the return of the sets for credit. These letters were accompanied by a customer ship history/business reply form, which listed the specific set list numbers and lot numbers shipped to the direct account. The direct accounts were requested to send copies of the enclosed recall letter with the listing of all affected sets to their subaccounts. Abbott sent recall letters dated 6/13/03 to those accounts who received I.V. set list 018810458, lot 910824W packed in cases with Liposyn II 20% Kits, list 97920403, lot 92552DF and list 97930403, lot 94553DF. These accounts were informed of the problem with the administration sets and were requested to remove the sets from the Liposyn II cases and return the sets for credit. Abbott sent recall letters dated 7/7/03 to distributors and veterinary clinics receiving the 12 additional lots of primary I.V. sets, list numbers 018810448 and 089620448, informing them of the problem with the drip chambers and requesting them to return the affected lots for credit. The distributors were requested to notify their customers. Abbott sent recall letters dated 7/7/03 to the third party manufacturers receiving the affected drip chamber components, informing them of the problem with the drip chambers and requesting the return of the affected lots. Abbott sent recall letters dated 8/19/03 to hospitals and distributors receiving the 9 additional lots of I.V. sets, list numbers 119440402, 119480402, 120300412, 122590402 and 123120401, informing them of the problem with the drip chambers and requesting them to return the affected lots for credit. The distributors were requested to notify their customers. Abbott sent recall letters dated 5/13/04 to hospitals and distributor

Device

Device Recall Abbott LifeShield, Abbott Plumset, Abbott Soluset Pump Sets
  • 모델명 / 제조번호(시리얼번호)
    a) LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line, Convertible Pin, 110 Inch, list 011690402, lots 90113NS, 92071NS, 94087NS, 94139NS, 96080NS; b) Latex-Free Enteral PlumSet, Vented, 98 Inch, list 014790402, lots 86119HG, 88086HG; c) Latex-Free Enteral PlumSet, Vented, 98 Inch, list 014794202, lot 87127HG; d) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch, list 016420448, lots 010365H, 011205H, 900955H, 910495H, 911415H, 920165H, 920665H, 930325H, 930865H, 931125H, 940725H, 940735H, 941405H, 941735H, 950165H, 950885H, 951205H, 961355H, 961625H; e) LifeShield Latex-Free Secondary I.V. PlumSet, Convertible Pin, 32 Inch, list 016430448, lot 941635H; f) LifeShield Latex-Free High-Pressure Filter Primary I.V. PlumSet, Convertible Pin, 112 Inch, list 016440448, lot 911275H; g) LifeShield Latex-Free High-Pressure Filter Primary I.V. PlumSet, Convertible Pin, 112 Inch, list 016450448, lot 950085H; h) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch, list 016460448, lots 911105H, 941455H;  i) Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch, list 016480448, lots 900965H, 901025H, 930875H; j) Latex-Free Primary I.V. PlumSet -OL, Convertible Pin, list 016486148, lots 890695H, 890755H, 890765H, 910205H, 910505H, 911425H, 911435H, 921595H, 921605H, 930615H, 940435H; k) Lifeshield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch, list 016500448, lots 881515H, 900415H, 901615H, 911095H, 931135H, 941745H, 951215H, 961615H; l) Latex-Free, Primary I.V. Plumset ¿ OL, Convertible Pin, 104 Inch, list 016516148, lots 891265H, 891275H, 891285H, 901575H, 901585H, 930345H, 930725H, 930735H, 941225H; m) LifeShield Latex-Free Microdrip Primary I.V. PlumSet, Convertible Pin, 104 Inch, list 017350478, lot 911045H; n) Latex-Free Soluset 150 mL Burette I.V. Pump Set, Vented, 114 Inch, list 017530402, lots 87121HG, 87173HG, 88064HG, 88101HG, 89048HG, 911555H; o) Latex-Free Nitroglycerin Primary I.V. Pump Set, Convertible Pin, 107 Inch, list 017720478, lot 900265H; p) LifeShield Latex-Free Microdrip Nitroglycerin PlumSet, Convertible Pin, 107 Inch, list 024270478, lot 930625H;  q) LifeShield Latex-Free Microdrip Nitroglycerine PlumSet, Convertible Pin, list 024276178, lot 950185H; r) Latex-Free Primary I.V. Pump Set, Convertible Pin, 105 Inch, list 037040478, lots 021255H, 890395H, 900475H, 901375H, 901385H, 910265H, 920245H, 940305H; s) Latex-Free Primary I.V. PlumSet, Convertible Pin, 107 Inch, list 064400412, lots 890165H, 920465H, 941415H t) LifeShield Latex-Free Microdrip Soluset 50 mL Burette PlumSet, Convertible Pin, 105 Inch, list 064460403, lot 87136HG; u) Latex-Free Enteral PlumSet with Integral Container, Nonvented, 105 Inch, list 064920402, lots 031024W, 88046HG; v) Latex-Free Microdrip Primary I.V. Micro Pump Set, Vented, 102 Inch, list 092430448, lots 891975H, 920065H; w) Latex-Free Soluset Microdrip 150 mL Burette Micro Pump Set, Vented, 124 Inch, list 092470468, lots 88063HG, 88152HG, 89061HG; x) Latex-Free Specialty I.V. Pump Set-HB, Convertible Pin, 105 Inch, list 111550478, lot 88149HG; y) LifeShield Latex-Free HEMA Blood PlumSet, Nonvented, 110 Inch, list 112350403, lots 87037HG, 88104HG, 89101HG, 920855H, 940175H; z) LifeShield Latex-Free Hemoset 100 mL Burette I.V. PlumSet, Nonvented, 105 Inch, list 112410403, lots 85031HG, 87169HG, 90013HG, 921515H; aa) Latex-Free Primary I.V. PlumSet, Nonvented, 112 Inch, list 113400402, lots 86082HG, 910625H, 930825H, 950555H, 961085H; bb) LifeShield Latex-Free Secondary I.V. PlumSet, Convertible Pin, 18 Inch, list 114170478, lots 900665H, 930555H; cc) LifeShield Latex-Free Primary I.V. PlumSet, Nonvented, 104 Inch, list 114190412, lots 011215H, 951095H; dd) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch, list 115940412, lots 87074HG, 920405H;  ee) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch, list 115950412, lots 85164HG, 941665H; ff) Latex-Free Primary I.V. Pump Set, Convertible Pin, 110 Inch, list 116060401, lots 850515H, 881345H; gg) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch, list 116620412, lots 930785H, 950565H; hh) LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 Inch, list 116640403, lots 85052HG, 910705H, 920555H, 941005H, 950305H, 951015H; ii) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch, list 116870401, lot 010915H; jj) LifeShield Latex-Free Primary I.V. Pump Set, Convertible Pin, 105 Inch, list 116970448, lots 891235H, 940595H; kk) Latex-Free Soluset 150 mL Burette PlumSet, Convertible Pin, 114 Inch, list 117060402, lots 87144HG, 88105HG, 89049HG, 930135H; ll) LifeShield Latex-Free Microdrip Soluset 150 mL Burette PlumSet, Convertible Pin, 124 Inch, list 117140402, lot 89097HG; mm) LifeShield Latex-Free HEMOSET, 100 mL Burette I.V. PlumSet, Nonvented, 141 Inch, list 118500402, lot 942025H; nn) Latex-Free Secondary I.V. PlumSet, Convertible Pin, 18 Inch, list 118770448, lots 900295H, 920485H, 940415H, 960145H; oo) Latex-Free Nitroglycerin PlumSet, Convertible Pin, 107 Inch, list 118780412, lots 901445H, 910635H, 920415H, 930565H, 941685H, 951135H; pp) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch, list 118840458, lots 01016R5, 88088HG, 92047R5, 93053R5; qq) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch, list 119430412, lots 010385H, 010985H, 020155H, 020165H, 020175H, 020605H, 891475H, 891595H, 891605H, 891625H, 891635H, 900425H, 900435H, 900445H, 900455H, 900985H, 920175H, 920185H, 930245H, 930365H, 930375H, 930385H, 930635H, 930645H, 930655H, 930665H, 930885H, 931145H, 931155H, 931165H, 940445H, 940455H, 940465H, 940475H, 940485H, 940745H, 940755H, 940765H, 940775H, 941265H, 941275H, 941285H, 941465H, 941475H, 941755H, 941765H, 941775H, 950245H, 950255H, 950265H, 950625H, 951235H; rr) LifeShield Latex-Free Microdrip Soluset with High-Pressure Filter 150 mL Burette PlumSet, Convertible Pin, 139 Inch, list 119440402, lots 84133HG, 84156HG, 88076HG, ****050035H****; ss) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 112 Inch, list 119460412, lots 84180HG, 930285H, 940335H, 940605H; tt) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch, list 119470412, lot 941185H; uu) LifeShield Latex-Free Microdrip Soluset 150 mL Burette PlumSet, Convertible Pin, 124 Inch, list 119480402, lots 84022HG, 85023HG, 87034HG, 87146HG, 87182HG, 87183HG, 88065HG, 88107HG, 940195H, 940895H, 950315H, 951345H, ****051895, 052345H****; vv) LifeShield Latex-Free Microdrip Soluset with High-Pressure Filter 150 mL Burette PlumSet, Convertible Pin, 139 Inch, list 119490402, lot 88108HG; ww) Latex-Free Microdrip Soluset 150 mL Burette Pump Set, Convertible Piercing Pin, 124 Inch, list 119760402, lots 88109HG, 89063HG, 90002HG, 911775H; xx) LifeShield Latex-Free Microdrip Soluset 150 mL Burette PlumSet, Convertible Pin, 124 Inch, list 119770403, lots 88131HG, 89124HG, 920865H, 961055H; yy) LifeShield Latex-Free Soluset 150 mL Burette I.V. PlumSet, Convertible Pin, 114 Inch, list 119790402, lot 87147HG; zz) LifeShield Latex-Free Microdrip Soluset with High-Pressure Filter 150 mL Burette PlumSet, Convertible Pin, 139 Inch, list 119800403, lots 89051HG, 960905H; aaa) Latex-Free Nitroglycerin Primary I.V. Pump Set, Convertible Pin, 110 Inch, list 119930478, lots 910145H, 920125H; bbb) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch, list 120300412, lots 021365H, 860795H, 860815H, 860955H, 871125H, 881455H, 881505H, 881525H, 890795H, 891295H, 891645H, 892075H, 901005H, 901335H, 901345H, 901355H, 911125H, 920205H, 920215H, 930895H, 940505H, 940515H, 941485H, 941785H, ****030685H, 030695H, 040445H****; ccc) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch, list 121190412, lot 960645H; ddd) LifeShield Latex-Free Primary I.V. Pump Set, Convertible Pin, 110 Inch, list 121610401, lots 86121HG, 87105NS, 89111NS, 89158NS, 90072NS; eee) LifeShield Latex-Free Primary I.V. Pump Set, Convertible Pin, 110 Inch, list 121620401, lots 01061NS, 89112NS; fff) LifeShield Latex-Free Primary I.V. Pump Set, Convertible Pin, 110 Inch, list 121630401, lots 88173HG, 89139NS; ggg) LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 Inch, list 122590402, lots 010775H, 030885H, 85045HG, 87031HG, 87148HG, 88057HG, 880805H, 890465H, 891745H, 901505H, 930165H, 940205H, 951355H, 960385H, ****040825H, 050845H****; hhh) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch, list 122600412, lots 010055H, 900375H, 900395H, 920155H, 921765H, 930055H, 940065H, 940425H, 961125H; iii) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch, list 123390412, lot 931075H; jjj) LifeShield Latex-Free Primary I.V. Pump Set, Convertible Pin, 110 Inch, list 123830401, lots 87004HG, 87174HG, 88132HG, 891325H, 911325H, 960395H; kkk) LifeShield Latex-Free Fat Emulsion I.V. PlumSet, Convertible Pin, 104 Inch, list 125380448, lot 951435H; lll) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 112 Inch, list 125630412, lot 951455H; mmm) LifeShield Latex-Free 150 mL Burette PlumSet, Convertible Pin, 114 Inch, list 125640402, lot 951485H; nnn) LifeShield Latex-Free GemStar Primary Piggyback Pump Set-SL, Convertible Pin, 110 Inch, list 132670401, lot 942315H; ooo) Latex-Free GemStar Primary Piggyback I.V. Pump Set-SL, list 132686101, lots 86106HG, 88042HG; ppp) Latex-Free Enteral PlumSet, Nonvented, 98 Inch, list 190140402, lots 87132HG, 942095H, 93049R5, 93050R5, 95022R5; qqq) Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch, list 190430412, lot 88089HG; rrr) LifeShield Latex-Free Primary I.V. PlumSet, Nonvented, 113 Inch, list 190500412, lots 911255H, 950045H; sss) LifeShield Latex-Free Nitroglycerin Primary I.V. PlumSet, Convertible Pin, 107 Inch, list 190860412, lot 93033R5; ttt) LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 118 Inch, list 191210402, lots 87153HG, 88056HG; uuu) LifeShield Latex-Free Primary I.V. Plumset, Convertible Pin, 104 Inch, list 192100412, lots 89110HG, 93044R5, 96039R5; vvv) LifeShield Latex-Free Microdrip Soluset with High-Pressure Filter 150 mL Burette PlumSet, Convertible Pin, 124 Inch, list 192310412, lot 85181HG zzz) LifeShield Latex-Free 50 mL Burette PlumSet, Convertible Pin, 107 Inch, list 192540402, lot 89128HG; aaaa) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 135 Inch, list 192650448, lots 86036R5, 89029R5, 92044R5, 96018R5; bbbb) LifeShield Latex-Free Microdrip Soluset 100 mL Burette PlumSet, Convertible Pin, 121 1/2 Inch, list 192890402, lots 85034HG, 85059HG, 88083HG, 960445H; cccc) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 103 Inch, list 193060412, lots 01019R5, 92042R5, 92043R5, 941395H; dddd) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 110 Inch, list 193380412, lots 01026R5, 87170HG, 92046R5; eeee) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 108 Inch, list 193400412, lots 02058R5, 94040R5;  ffff) LifeShield Latex-Free Microdrip Soluset with High-Pressure Filter 150 mL Burette PlumSet, Convertible Pin, 137 Inch, list 193470402, lot 960945H; gggg) LifeShield Latex-Free Soluset 100 mL Burette PlumSet, Convertible Pin, 121 Inch, list 193510402, lots 84043HG, 911825H, 950355H; hhhh) LifeShield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 Inch, list 193600412, lots 88163HG, 88169HG, 921785H; ****iiii) LifeSHield Latex-Free Primary I.V. PlumSet, Convertible Pin, 104 inch, list 190910465, lot 02044R5****
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and Internationally to Abbott affiliates in Argentina, Aruba, Australia, the Bahamas, Barbados, Bermuda, Bolivia, Brazil, Canada, Cayman Islands, Chile, Columbia, Costa Rica, Croatia, Curacao, Dominican Republic, Ecuador, Egypt, El Salvador, France, Greece, Guam, Guatemala, Haiti, Honduras, Hong Kong, Hungary, Italy, Jordan, Kuwait, Mexico, New Zealand, Nicaragua, Pakistan, Panama, Paraguay, Peru, Suadia Arabia, Singapore, Taiwan, Trinidad, Turkey, United Arab Emirates and Uruguay
  • 제품 설명
    I.V. Pump Sets with Cassettes for use with Abbott Plum Series and Lifecare Infusion Pumps; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 86 different sets listed in the code information section below.
  • Manufacturer
    Abbott Laboratories HPD/ADD

Manufacturer

Abbott Laboratories HPD/ADD
  • 제조사 주소
    Abbott Laboratories HPD/ADD, 100/200 Abbott Park Road, Abbott Park IL 60064
  • Source
    USFDA