Device Recall Abbott & Abbott LifeShield I.V. Extension Sets

  • 모델명 / 제조번호(시리얼번호)
    a) LifeShield Latex-Free Pediatric Extension Set, 10.5 Inch, list 026940468, lots 910085H, 940405H; b) LifeShield Latex-Free Pressure Activated Valve Extension Set with Locking Spin Collar ''T'', list 047300402, lots 87080NS, 89099HG; c) LifeShield Latex-Free VeniLoop Connector, list 114810401, lot 891085H; d) LifeShield Latex-Free Microbore Extension Set, 7 Inch, list 119570402, lots 88057NS, 88103NS; e) LifeShield Latex-Free Microbore Extension Set, list 119580401, lots 87084NS, 88056NS, 88078NS, 89088NS, 89143NS, 89181NS;  f) LifeShield Latex-Free Microbore Extension Set with Clave, Locking Spin Collar ''T'' and Prepierced Injection Site, list 120530401, lots 86107NS, 87126NS, 88125NS; g) LifeShield Latex-Free Macrobore Extension Set, 7 Inch, list 120940402, lots 021045H, 88028HG, 88029HG, 88030HG, 88031HG, 891045H, 891875H, 891885H, 900165H, 900175H, 901015H, 910235H, 911485H, 920225H, 920785H, 921485H, 930425H, 930925H, 931205H, 940835H; h) LifeShield Latex-Free Microbore Extension Set, 7 Inch, list 121130402, lot 87127NS; i) LifeShield Latex-Free Macrobore Extension Set, list 123120401, lots 891095H, 910555H, 960775H, **** 040755H****; j) LifeShield Latex-Free Microbore Extension Set, list 123130402, lots 86002HG, 86044HG, 87012HG, 87119HG, 90016HG, 90081NS, 92144NS; k) LifeShield Latex-Free Microbore Extension Set INT, 6 Inch, list 123320401, lot 931375H; l) LifeShield Latex-Free Tri-Leg Microbore Extension Set, list 123340401, lots 880605H, 891895H, 930945H, 950675H; m) LifeShield Latex-Free Tri-Leg Extension Set, list 123460401, lots 88122HG, 89115HG, 920815H; n) LifeShield Latex-Free Microbore Extension Set, list 124390401, lot 88176HG; o) LifeShield Latex-Free Extension Set, 6 Inch, list 191420448, lots 87188HG, 89021HG, 93025R5; p) Sterile Latex-Free Microbore Extension Set, list 191700204, lot 89135HG; q) Sterile Latex-Free Microbore Extension Set, list 191700404, lots 010115H, 892045H, 911495H, 930965H, 940855H;  r) Microbore Extension Set, list 191700415, lot 961935H s) LifeShield Latex-Free Macrobore Extension Set, 46 Inch, list 192220448, lots 921425H, 960425H; t) LifeShield Latex-Free Y-Type Connecting Set, 9 Inch, list 193130448, lots 88138HG, 881405H, 941705H u) LifeShield Latex-Free Macrobore Extension Set, list 193280448, lots 900545H, 910305H; v) LifeShield Latex-Free Microbore Extension Set, 19 Inch, list 193320448, lot 02043R5;  Please Note: items p, q & r (list 191700204, 191700404 and 191700415) were packaged in kits with Sporanox Injection distributed by Ortho Biotech Products, Raritan, NJ 08869.
  • 의료기기 분류등급
  • 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. Extension Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 22 different sets listed in the code information section below. Please Note: items p, q & r (list 191700204, 191700404 and 191700415) were packaged in kits with Sporanox Injection distributed by Ortho Biotech Products, Raritan, NJ 08869.
  • Manufacturer
  • 1 Event

제조사

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