CareFusion 303, Inc.: Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system

Hazard

Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.

Details from the source

Reason for recall: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, 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, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of United Arab Emirates, Australia, Belgium, Canada, Hungary, Kuwait, Qatar, Saudi Arabia, Singapor Quantity: 125017 device (finished devices and kits) Lot/code info: Model Number: 8015 UDI-DI codes: 10885403516023, 10885403515231, 10885403801549, 10885403801532, 10885403801518, 10885403519284, 10885403519215 Serial Numbers: 16405753 16405872 16376937 16389635 16405929 16385933 16392029 16405859 16355147 16385733 16356177 16358090 16405681 16405365 16391644 16365407 16380736 16406383 16370288 16342333 16406520 16340432 16406486 16342209 16339360 16356089 16379852 16406293 16365679 16343510 16340086 16394051 16372192 16406547 16392519 16342393 16370109 16378495 16380421 16406296 16366356 16406474 16376814 16333959 16390881 16355769 16405567 16405941 16380737 16406213 16391082 16405988 16340999 16334088 16370963 16405969 16406245 16406332 16406224 16386484 16406461 16394270 16406295 16381987 16405986 16337357 16405861 16373958 16388828 16406482 16377465 16406473 16378711 16343560 16388488 16384288 16342306 16342387 16355791 16366771 16406518 16398407 16392150 16339100 16339855 16385755 16386553 16360664 16394173 16406317 16388663 16389674 16406471 16390470 16402464 16341647 16365652 16405580 16343049 16390351 16365011 16406536 16406484 16357255 16344098 16405945 16405623 16340058 16381253 16398304 16406479 16405601 16392485 16406540 16374550 16339803 16406524 16377605 16372148 16406514 16406539 16340891 16406457 16339474 16370175 16340358 16406543 16369665 16366663 16341788 16380626 16406511 16406502 16406519 16400608 16405768 16406552 16406517 16405448 16203194 16202076 16202216 16202221 16203212 16202062 16203196 16202042 16203116 16203187

UPC codes

10885403516023, 10885403515231, 10885403801549, 10885403801532, 10885403801518, 10885403519284, 10885403519215

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.