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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2031-2014

GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products.

Publicado el 16 de julio de 2014 · Inicio del retiro: 31 de enero de 2014

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 connection between the beeper subassembly and the pump may fail. The GemStar infusion pump will identify this failure during the "self-test" while powering up which will result in a Beeper Error ("code 10/001/000"). This Beeper Error (code 10/001/000) is a service alarm that places the pump in an inoperable mode and requires service before it can be returned to service.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Hospira Inc.
Distribuidor
Worldwide Distribution - US: Nationwide in the state of 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 including District Of Columbia, Guam, Puerto Rico; and the countries of Austria, Australia, Bahrain, Belgium, Canada, Chile, France, Germany, Greece, Guatemala, Hong Kong, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Netherlands, Oman, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela
Lote
1) List Number: 13000; Serial Numbers: 9221423 , 12470045 , 12470063 , 12470085 , 12470109 , 12470130 , 12470133 , 12470135 , 12470138 , 12470144 , 12470145 , 12470147 , 12470152 , 12470153 , 12470154 , 12470156 , 12470157 , 12470158 , 12470160 , 12470162 , 12470163 , 12470164 , 12470165 , 12470167 , 12470168 , 12470169 , 12470171 , 12470172 , 12470173 , 12470174 , 12470177 , 12470180 , 12470207 , 12470208 , 12470209 , 12470220 , 12470225 , 12470239 , 12470243 , 12470244 , 12470257 , 12470258 , 12470259 , 12470262 , 12470268 , 12470273 , 12470279 , 12470281 , 12470283 , 12470285 , 12470290 , 12470294 , 12470299 , 12470301 , 12470303 , 12470304 , 12470305 , 12470319 , 12470320 , 12470321 , 12470332 , 12470335 , 12470337 , 12470338 , 12470340 , 12470341 , 12470346 , 12470347 , 12470350 , 12470354 , 12470357 , 12470360 , 12470361 , 12470362 , 12470365 , 12470366 , 12470367 , 12470369 , 12470370 , 12470375 , 12470378 , 12470381 , 12470383 , 12470385 , 12470386 , 12470387 , 12470389 , 12470390 , 12470391 , 12470392 , 12470393 , 12470395 , 12470396 , 12470397 , 12470399 , 12470402 , 12470408 , 12470411 , 12470412 , 12470413 , 12470416 , 12470417 , 12470418 , 12470424 , 12470425 , 12470428 , 12470433 , 12470434 , 12470435 , 12470439 , 12470440 , 12470441 , 12470442 , 12470444 , 12470447 , 12470448 , 12470449 , 12470452 , 12470453 , 12470455 , 12470457 , 12470458 , 12470459 , 12470464 , 12470465 , 12470470 , 12470472 , 12470473 , 12470477 , 12470479 , 12470487 , 12470489 , 12470492 , 12470496 , 12470500 , 12470501 , 12470503 , 12470505 , 12470506 , 12470511 , 12470513 , 12470514 , 12470516 , 12470518 , 12470519 , 12470520 , 12470521 , 12470526 , 12470528 , 12470529 , 12470531 , 12470532 , 12470539 , 12470540 , 12470541 , 12470543 , 12470545 , 12470549 , 12470550 , 12470552 , 12470553 , 12470557 , 12470561 , 12470562 , 12470567 , 12470569 , 12470570 , 12470571 , 12470576 , 12470577 , 12470578 , 12470579 , 12470581 , 12470583 , 12470588 , 12470589 , 12470590 , 12470591 , 12470594 , 12470598 , 12470600 , 12470602 , 12470603 , 12470604 , 12470605 , 12470607 , 12470608 , 12470612 , 12470614 , 12470615 , 12470616 , 12470618 , 12470619 , 12470621 , 12470625 , 12470626 , 12470628 , 12470629 , 12470630 , 12470631 , 12470632 , 12470633 , 12470634 , 12470636 , 12470637 , 12470638 , 12470640 , 12470642 , 12470643 , 12470644 , 12470645 , 12470647 , 12470648 , 12470650 , 12470651 , 12470652 , 12470653 , 12470654 , 12470655 , 12470656 , 12470659 , 12470660 , 12470664 , 12470666 , 12470667 , 12470668 , 12470672 , 12470673 , 12470676 , 12470677 , 12470678 , 12470681 , 12470683 , 12470685 , 12470686 , 12470687 , 12470691 , 12470693 , 12470694 , 12470695 , 12470697 , 12470698 , 12470701 , 12470703 , 12470704 , 12470705 , 12470706 , 12470707 , 12470713 , 12470716 , 12470719 , 12470720 , 12470721 , 12470722 , 12470725 , 12470726 , 12470727 , 12470734 , 12470736 , 12470739 , 12470741 , 12470742 , 12470744 , 12470745 , 12470747 , 12470749 , 12470750 , 12470751 , 12470752 , 12470755 , 12470776 , 12470779 , 12470782 , 12470783 , 12470786 , 12470787 , 12470791 , 12470793 , 12470794 , 12470798 , 12470801 , 12470802 , 12470804 , 12470809 , 12470811 , 12470818 , 12470819 , 12470820 , 12470821 , 12470827 , 12470829 , 12470831 , 12470833 , 12470834 , 12470839 , 12470841 , 12470842 , 12470844 , 12470845 , 12470847 , 12470848 , 12470849 , 12470850 , 12470851 , 12470852 , 12470853 , 12470855 , 12470856 , 12470857 , 12470858 , 12470859 , 12470860 , 12470861 , 12470862 , 12470863 , 12470864 , 12470868 , 12470869 , 12470870 , 12470871 , 12470872 , 12470874 , 12470875 , 12470876 , 12470882 , 12470883 , 12470884 , 12470885 , 12470889 , 12470890 , 12
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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