Device Recall Plum A Hyperbaric Infusion Pump

List No. 11005; Serial Numbers: 16792201, 16792202, 16792205, 16792206, 16792208, 16792209, 16792210, 16792211, 16792213, 16792216, 16792217, 16792219, 16792220, 16792222, 16792223, 16792224, 16792225, 16792226, 16792227, 16792228, 16792230, 16792232, 16792233, 16792234, 16792235, 16792236, 16792238, 16792239, 16792240, 16792241, 16792242, 16792244, 16792245, 16792246, 16792248, 16792249, 16792250, 16792251, 16792252, 16792253, 16792254, 16792255, 16792256, 16792257, 16792258, 16792259, 16792260, 16792261, 16792263, 16792264, 16792265, 16792266, 16792268, 16792269, 16792271, 16792272, 16792273, 18807402, 18807405, 18807406, 18807407, 18807408, 18807409, 18807410, 18807413, 18807414, 18807417, 18807418, 18807420, 18807421, 18807423, 18807427, 18807428, 18807429, 18807430, 18807431, 18807432, 18807433, 18807434, 18807439, 18807443, 18807444, 18807446, 18807449, 18807452, 18807453, 18807455, 18807456, 18807459, 18807463, 18807466, 18807472, 18807474, 18807478, 18807484, 18807485, 18807486, 18807490, 18807491, 18807494, 18807496, 18807499, 18807500, 18807501, 18807506, 18807509, 18807510, 18807511, 18807513, 18807514, 18807518, 18807523, 18807524, 18807529, 18807535, 18807536, 18807539, 18807540, 18807541, 18807542, 18807543, 18807545, 18807546, 18807556, 18807557, 18807568, 18807574, 18807575, 18807576, 18807578, 18807581, 18807584, 18807585, 18807586, 18807588, 18807589, 18807590, 18807591, 18807596, 18807597, 18807598, 18807599, 18807600, 18807601, 18807602, 18807604, 18807605, 18807607, 18807608, 18807609, 18807610, 18807611, 18807612, 18807613, 18807614, 18807617, 18807618, 18807619, 18807620, 18807623, 18807625, 18807626, 18807627, 18807628, 18807630, 18807631, 18807632, 18807633, 18807634, 18807636, 18807637, 18807639, 18807640, 18807695, 18807696, 18807697, 18807698, 18807699, 18807700

General Hospital and Personal Use Devices

2

No

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, SI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Croatia, Dominican Republic, Turks and Caicos.

Plum A+ Hyperbaric Infusion Pump; || List Number 11005; || Labeled in part: PLUM A+ HYPERBARIC; || Product Usage: || The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care

1) List Number 11005; Serial Numbers: 16792201 , 16792202 , 16792205 , 16792206 , 16792208 , 16792209 , 16792210 , 16792211 , 16792213 , 16792216 , 16792217 , 16792219 , 16792220 , 16792222 , 16792223 , 16792224 , 16792225 , 16792226 , 16792227 , 16792228 , 16792230 , 16792232 , 16792233 , 16792234 , 16792235 , 16792236 , 16792238 , 16792239 , 16792240 , 16792241 , 16792242 , 16792244 , 16792245 , 16792246 , 16792248 , 16792249 , 16792250 , 16792251 , 16792252 , 16792253 , 16792254 , 16792255 , 16792256 , 16792257 , 16792258 , 16792259 , 16792260 , 16792261 , 16792263 , 16792264 , 16792265 , 16792266 , 16792268 , 16792269 , 16792271 , 16792272 , 16792273 , 18807402 , 18807405 , 18807406 , 18807407 , 18807408 , 18807409 , 18807410 , 18807413 , 18807414 , 18807417 , 18807418 , 18807420 , 18807421 , 18807423 , 18807427 , 18807428 , 18807429 , 18807430 , 18807431 , 18807432 , 18807433 , 18807434 , 18807439 , 18807443 , 18807444 , 18807446 , 18807449 , 18807452 , 18807453 , 18807455 , 18807456 , 18807459 , 18807463 , 18807466 , 18807472 , 18807474 , 18807478 , 18807484 , 18807485 , 18807486 , 18807490 , 18807491 , 18807494 , 18807496 , 18807499 , 18807500 , 18807501 , 18807506 , 18807509 , 18807510 , 18807511 , 18807513 , 18807514 , 18807518 , 18807523 , 18807524 , 18807529 , 18807535 , 18807536 , 18807539 , 18807540 , 18807541 , 18807542 , 18807543 , 18807545 , 18807546 , 18807556 , 18807557 , 18807568 , 18807574 , 18807575 , 18807576 , 18807578 , 18807581 , 18807584 , 18807585 , 18807586 , 18807588 , 18807589 , 18807590 , 18807591 , 18807596 , 18807597 , 18807598 , 18807599 , 18807600 , 18807601 , 18807602 , 18807604 , 18807605 , 18807607 , 18807608 , 18807609 , 18807610 , 18807611 , 18807612 , 18807613 , 18807614 , 18807617 , 18807618 , 18807619 , 18807620 , 18807623 , 18807625 , 18807626 , 18807627 , 18807628 , 18807630 , 18807631 , 18807632 , 18807633 , 18807634 , 18807636 , 18807637 , 18807639 , 18807640 , 18807695 , 18807696 , 18807697 , 18807698 , 18807699 , 18807700

General Hospital and Personal Use Devices

2

No

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.

The Plum A+ Hyperbaric 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+ Hyperbaric 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+ Hyperbaric 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.