FDAFDA · Food and drugs·Recall number 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.

Published July 16, 2014 · Recall initiated: January 31, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: Hospira Inc.
Distributor: 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
Lot: 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
Risk classification: Class II
Area (FDA): device
Country: United States

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