FDAFDA · Food and drugs·Recall number Z-1517-2015
The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits.
Published April 29, 2015 · Recall initiated: February 27, 2013
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 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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Hospira Inc.
- Distributor
- 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.
- Lot
- 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 ,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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