FDAFDA · Food and drugs·Recall number Z-0289-2014
The Plum A+3 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+3 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+3 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 20678; Serial Numbers: 15541001 , 15541011 , 15541021 , 15541031 , 15541041 , 15541051 , 15541061 , 15541071 , 15541081 , 15541091 , 15541101 , 15541111 , 15541121 , 15541131 , 15541141 , 15541151 , 15541161 , 15541171 , 15541181 , 15541191 , 15541201 , 15541211 , 15541231 , 15541241 , 15541261 , 15541271 , 15541281 , 15541291 , 15541301 , 15541311 , 15541321 , 15541331 , 15541341 , 15541351 , 15541361 , 15541371 , 15541381 , 15541391 , 15541401 , 15541411 , 15541421 , 15541431 , 15541441 , 15541451 , 15541461 , 15541471 , 15541481 , 15541491 , 15541501 , 15541511 , 15541521 , 15541531 , 15541541 , 15541551 , 15541561 , 15541571 , 15541581 , 15541591 , 15541601 , 15541611 , 15541621 , 15541631 , 15541641 , 15541651 , 15541661 , 15541671 , 15541681 , 15541691 , 15541701 , 15541711 , 15541721 , 15541731 , 15541741 , 15541751 , 15541761 , 15541771 , 15541781 , 15541791 , 15541801 , 15541811 , 15541821 , 15541831 , 15541841 , 15541851 , 15541861 , 15541871 , 15541881 , 15541891 , 15541901 , 15541911 , 15541921 , 15541931 , 15541941 , 15541951 , 15541961 , 15541971 , 15541981 , 15541991 , 15542001 , 15542011 , 15542021 , 15542031 , 15542041 , 15542051 , 15542061 , 15542071 , 15542081 , 15542091 , 15542101 , 15542111 , 15542121 , 15542131 , 15542141 , 15542151 , 15542161 , 15542171 , 15542181 , 15542191 , 15542201 , 15542211 , 15542221 , 15542231 , 15542241 , 15542251 , 15542261 , 15542271 , 15542281 , 15542291 , 15542301 , 15542311 , 15542321 , 15542331 , 15542341 , 15542351 , 15542361 , 15542371 , 15542381 , 15542391 , 15542401 , 15542411 , 15542431 , 15542441 , 15542451 , 15542461 , 15542471 , 15542481 , 15542491 , 15542501 , 15542511 , 15542521 , 15542531 , 15542541 , 15542551 , 15542561 , 15542571 , 15542581 , 15542591 , 15542601 , 15542611 , 15542621 , 15542631 , 15542641 , 15542651 , 15542661 , 15542671 , 15542681 , 15542691 , 15542701 , 15542711 , 15542721 , 15542731 , 15542741 , 15542751 , 15542761 , 15542771 , 15542781 , 15542791 , 15542801 , 15542811 , 15542821 , 15542831 , 15542841 , 15542851 , 15542861 , 15542871 , 15542881 , 15542891 , 15542911 , 15542921 , 15542931 , 15542941 , 15542951 , 15542961 , 15542971 , 15542981 , 15542991 , 15543001 , 15543011 , 15543021 , 15543031 , 15543041 , 15543051 , 15543061 , 15543071 , 15543081 , 15543101 , 15543111 , 15543121 , 15543131 , 15543141 , 15543151 , 15543161 , 15543181 , 15543191 , 15543211 , 15543221 , 15543231 , 15543241 , 15543261 , 15543271 , 15543281 , 15543291 , 15543301 , 15543311 , 15543321 , 15543331 , 15543341 , 15543351 , 15543361 , 15543371 , 15543391 , 15543401 , 15543411 , 15543421 , 15543431 , 15543441 , 15543451 , 15543461 , 15543471 , 15543481 , 15543491 , 15543501 , 15543511 , 15543521 , 15543531 , 15543541 , 15543551 , 15543571 , 15543581 , 15543591 , 15543601 , 15543611 , 15543621 , 15543631 , 15543641 , 15543651 , 15543661 , 15543671 , 15543681 , 15543691 , 15543711 , 15543721 , 15543731 , 15543741 , 15543751 , 15543761 , 15543771 , 15543781 , 15543791 , 15543801 , 15543811 , 15543821 , 15543831 , 15543841 , 15543851 , 15543861 , 15543871 , 15543881 , 15543891 , 15543901 , 15543911 , 15543921 , 15543931 , 15543941 , 15543951 , 15543961 , 15543971 , 15543981 , 15543991 , 15544001 , 15544011 , 15544021 , 15544031 , 15544041 , 15544051 , 15544061 , 15544071 , 15544081 , 15544091 , 15544101 , 15544111 , 15544121 , 15544131 , 15544141 , 15544151 , 15544161 , 15544191 , 15544201 , 15544211 , 15544221 , 15544231 , 15544241 , 15544251 , 15544261 , 15544271 , 15544281 , 15544291 , 15544301 , 15544311 , 15544321 , 15544331 , 15544341 , 15544351 , 15544371 , 15544381 , 15544401 , 15544411 , 15544421 , 15544431 , 15544441 , 1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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