FDAFDA · Alimentos y medicamentos·N.º oficial Z-1517-2015
The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits.
Publicado el 29 de abril de 2015 · Inicio del retiro: 27 de febrero de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication.
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- Hospira Inc.
- Distribuidor
- Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico, American Virgin Islands; and Internationally to Canada.
- Lote
- List 12384: Serial Numbers: 12920041 , 12920048 , 12920052 , 12920056 , 12920066 , 12920069 , 12920079 , 12920082 , 12920101 , 12920102 , 12920104 , 12920105 , 12920106 , 12920107 , 12920117 , 12920121 , 12920122 , 12920152 , 12920158 , 12920159 , 12920160 , 12920174 , 12920246 , 12920248 , 12920251 , 12920252 , 12920255 , 12920257 , 12920264 , 12920265 , 12920268 , 12920270 , 12920275 , 12920276 , 12920277 , 12920278 , 12920282 , 12920287 , 12920289 , 12920291 , 12920294 , 12920304 , 12920305 , 12920311 , 12920312 , 12920320 , 12920328 , 12920330 , 12920332 , 12920340 , 12920343 , 12920346 , 12920347 , 12920352 , 12920353 , 12920357 , 12920358 , 12920359 , 12920360 , 12920362 , 12920364 , 12920369 , 12920371 , 12920372 , 12920377 , 12920381 , 12920382 , 12920383 , 12920384 , 12920387 , 12920388 , 12920390 , 12920392 , 12920398 , 12920401 , 12920403 , 12920404 , 12920405 , 12920410 , 12920412 , 12920413 , 12920415 , 12920416 , 12920420 , 12920424 , 12920425 , 12920428 , 12920429 , 12920432 , 12920433 , 12920434 , 12920435 , 12920436 , 12920441 , 12920444 , 12920446 , 12920448 , 12920449 , 12920453 , 12920455 , 12920457 , 12920458 , 12920460 , 12920461 , 12920462 , 12920466 , 12920467 , 12920468 , 12920469 , 12920472 , 12920473 , 12920476 , 12920477 , 12920478 , 12920480 , 12920481 , 12920482 , 12920484 , 12920485 , 12920486 , 12920487 , 12920488 , 12920489 , 12920490 , 12920492 , 12920496 , 12920497 , 12920498 , 12920499 , 12920501 , 12920505 , 12920506 , 12920507 , 12920508 , 12920509 , 12920510 , 12920514 , 12920516 , 12920517 , 12920518 , 12920519 , 12920520 , 12920521 , 12920522 , 12920523 , 12920524 , 12920525 , 12920526 , 12920530 , 12920533 , 12920534 , 12920535 , 12920537 , 12920540 , 12920541 , 12920542 , 12920544 , 12920545 , 12920546 , 12920548 , 12920555 , 12920558 , 12920559 , 12920560 , 12920562 , 12920565 , 12920566 , 12920567 , 12920568 , 12920569 , 12920570 , 12920571 , 12920574 , 12920576 , 12920577 , 12920578 , 12920581 , 12920582 , 12920585 , 12920586 , 12920587 , 12920589 , 12920590 , 12920591 , 12920592 , 12920593 , 12920596 , 12920598 , 12920599 , 12920600 , 12920601 , 12920602 , 12920603 , 12920604 , 12920605 , 12920606 , 12920607 , 12920608 , 12920610 , 12920611 , 12920612 , 12920614 , 12920615 , 12920620 , 12920621 , 12920623 , 12920626 , 12920627 , 12920629 , 12920632 , 12920633 , 12920634 , 12920635 , 12920639 , 12920641 , 12920644 , 12920646 , 12920647 , 12920648 , 12920649 , 12920651 , 12920654 , 12920657 , 12920659 , 12920660 , 12920663 , 12920664 , 12920665 , 12920666 , 12920668 , 12920669 , 12920670 , 12920671 , 12920674 , 12920675 , 12920677 , 12920679 , 12920680 , 12920681 , 12920682 , 12920686 , 12920688 , 12920690 , 12920691 , 12920692 , 12920696 , 12920699 , 12920702 , 12920703 , 12920706 , 12920708 , 12920710 , 12920714 , 12920715 , 12920716 , 12920717 , 12920720 , 12920724 , 12920726 , 12920727 , 12920728 , 12920729 , 12920731 , 12920733 , 12920734 , 12920736 , 12920743 , 12920744 , 12920746 , 12920747 , 12920749 , 12920750 , 12920756 , 12920759 , 12920761 , 12920762 , 12920763 , 12920766 , 12920767 , 12920770 , 12920771 , 12920773 , 12920774 , 12920778 , 12920779 , 12920782 , 12920783 , 12920788 , 12920792 , 12920793 , 12920795 , 12920796 , 12920797 , 12920798 , 12920800 , 12920802 , 12920808 , 12920809 , 12920811 , 12920813 , 12920815 , 12920819 , 12920820 , 12920821 , 12920826 , 12920827 , 12920828 , 12920834 , 12920836 , 12920837 , 12920839 , 12920840 , 12920841 , 12920844 , 12920848 , 12920850 , 12920851 , 12920852 , 12920853 , 12920856 , 12920857 , 12920858 , 12920859 , 12920861 , 12920863 , 12920865 , 12920866 , 12920868 , 12920871 , 12920872 , 12920873 ,
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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