FDAFDA · Food and drugs·Recall number Z-0284-2014
The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
Published November 20, 2013 · Recall initiated: February 1, 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
Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hospira Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, 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 and U.S. Virgin Islands; and countries of: Costa Rica and Dominican Republic.
- Lot
- 1) List Number 11971; Serial Numbers: 13120009 , 13120017 , 13120018 , 13120019 , 13120026 , 13120028 , 13120037 , 13120041 , 13120042 , 13120044 , 13120057 , 13120058 , 13120068 , 13120071 , 13120074 , 13120075 , 13120082 , 13120096 , 13120103 , 13120104 , 13120107 , 13120108 , 13120109 , 13120115 , 13120128 , 13120138 , 13120143 , 13120153 , 13120160 , 13120164 , 13120168 , 13120171 , 13120174 , 13120177 , 13120186 , 13120187 , 13120200 , 13120205 , 13120220 , 13120222 , 13120223 , 13120226 , 13120231 , 13120235 , 13120237 , 13120238 , 13120239 , 13120247 , 13120248 , 13120249 , 13120251 , 13120253 , 13120262 , 13120270 , 13120271 , 13120277 , 13120279 , 13120285 , 13120293 , 13120294 , 13120295 , 13120297 , 13120303 , 13120310 , 13120311 , 13120314 , 13120320 , 13120329 , 13120343 , 13120344 , 13120346 , 13120353 , 13120354 , 13120357 , 13120359 , 13120365 , 13120366 , 13120367 , 13120370 , 13120385 , 13120390 , 13120391 , 13120394 , 13120398 , 13120399 , 13120401 , 13120405 , 13120419 , 13120422 , 13120424 , 13120440 , 13120441 , 13120452 , 13120460 , 13120462 , 13120467 , 13120472 , 13120483 , 13120487 , 13120496 , 13120502 , 13120503 , 13120508 , 13120537 , 13120543 , 13120549 , 13120557 , 13120558 , 13120563 , 13120565 , 13120567 , 13120568 , 13120576 , 13120580 , 13120582 , 13120585 , 13120586 , 13120589 , 13120591 , 13120593 , 13120595 , 13120596 , 13120598 , 13120599 , 13120606 , 13120607 , 13120611 , 13120612 , 13120613 , 13120615 , 13120626 , 13120627 , 13120629 , 13120630 , 13120634 , 13120639 , 13120644 , 13120659 , 13120661 , 13120665 , 13120666 , 13120676 , 13120677 , 13120683 , 13120684 , 13120692 , 13120698 , 13120705 , 13120707 , 13120710 , 13120712 , 13120721 , 13120723 , 13120725 , 13120726 , 13120737 , 13120743 , 13120751 , 13120759 , 13120769 , 13120772 , 13120780 , 13120784 , 13120788 , 13120802 , 13120808 , 13120823 , 13120826 , 13120827 , 13120829 , 13120835 , 13120836 , 13120837 , 13120842 , 13120846 , 13120850 , 13120855 , 13120857 , 13120858 , 13120863 , 13120865 , 13120867 , 13120868 , 13120871 , 13120872 , 13120877 , 13120881 , 13120885 , 13120887 , 13120891 , 13120894 , 13120896 , 13120902 , 13120906 , 13120909 , 13120919 , 13120922 , 13120924 , 13120937 , 13120940 , 13120941 , 13120942 , 13120943 , 13120946 , 13120947 , 13120950 , 13120956 , 13120967 , 13120970 , 13120973 , 13120978 , 13120991 , 13120997 , 13121020 , 13121035 , 13121040 , 13121044 , 13121045 , 13121050 , 13121052 , 13121059 , 13121061 , 13121077 , 13121078 , 13121082 , 13121086 , 13121088 , 13121092 , 13121093 , 13121095 , 13121105 , 13121106 , 13121108 , 13121111 , 13121112 , 13121118 , 13121129 , 13121130 , 13121140 , 13121143 , 13121149 , 13121150 , 13121153 , 13121163 , 13121164 , 13121174 , 13121179 , 13121191 , 13121198 , 13121199 , 13121201 , 13121207 , 13121210 , 13121214 , 13121231 , 13121232 , 13121233 , 13121236 , 13121237 , 13121238 , 13121245 , 13121246 , 13121248 , 13121250 , 13121253 , 13121259 , 13121260 , 13121265 , 13121269 , 13121276 , 13121277 , 13121280 , 13121281 , 13121284 , 13121291 , 13121301 , 13121313 , 13121314 , 13121317 , 13121345 , 13121348 , 13121352 , 13121353 , 13121365 , 13121369 , 13121370 , 13121371 , 13121378 , 13121382 , 13121387 , 13121394 , 13121396 , 13121399 , 13121400 , 13121406 , 13121418 , 13121425 , 13121427 , 13121429 , 13121430 , 13121438 , 13121446 , 13121450 , 13121470 , 13121476 , 13121477 , 13121480 , 13121488 , 13121492 , 13121493 , 13121495 , 13121499 , 13121500 , 13121543 , 13121546 , 13121551 , 13121560 , 13121566 , 13121568 , 13121569 , 13121581 , 13121583 , 13121594 , 13121595 , 13121605 , 13121632 , 13121640 , 13121641 , 13121661 , 13121671 , 1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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