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ENFORCEMENT REPORT FOR NOVEMBER 17

ENFORCEMENT REPORT FOR NOVEMBER 17 - ENFORCEMENT REPORT FOR...

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ENFORCEMENT REPORT FOR NOVEMBER 17, 2010 RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS I ___________________________________ PRODUCT 1) Baxter Colleague Single Channel Volumetric Infusion Pumps. Product Codes: 2M8151, 2M8161, and 2M9161. Recall # Z- 0001-2011; 2) Baxter Colleague Triple Channel Volumetric Infusion Pumps. Product Codes: 2M 8153 and 2M 8163. Recall # Z-0002-2011; CODE All serial numbers and all product numbers sold in the U.S. RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare, Corp., Round Lake, IL, by letters dated August 4, 2010. Manufacturer: Baxter Healthcare, Corp., Singapore, Singapore. Firm initiated recall is ongoing. REASON The FDA sent a letter to Baxter on April 30, 2010, ordering the company to recall and destroy all models of its Colleague Volumetric Infusion Pumps currently in use in the United States. FDA determined that this action is necessary, as Baxter has failed to adequately correct, within a reasonable timeframe, the deficiencies in the Colleague pumps still in use. VOLUME OF PRODUCT IN COMMERCE 302,872 pumps DISTRIBUTION Nationwide ___________________________________ PRODUCT CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems. Recall # Z-0006-2011 CODE Serial numbers: 2000442 12429705 12472445 12472467 2000459 12504572 12505895 12506067 12506678 12507138 12532242 12533702 12537538 12532809 12535532 12543319 12545566 12547607 12547100 12545185 12545412 12574661 12588224 12598759 12603323 12610885 12611059 12611661 12611673 12611494 12624559 12620674 12633542 12634419 12634750 12635196 12636530 12571561 12646928 12649474 12649792 12652146 12655077 12657023 12664180 12664430 12664645 12667150 12672199 12672462 12674214 12684932 12686784 12706868 12712296 12713259 12713539 12713863 12713731 12714368 12715266 12717187 12717405 12720021 12718312 12722132 12722680 12741043 12721966 12739358 12677074 12677951 12757873 12757886 12758505 12759075 12751761 12724528 12725627 12725659 12725690 12725766 12726504 12726705 12726739 12789095 12789098 12789099 12789100 12789112 12789113 12789114 12789118 12789119 12789138 12789139 12789140 12789141 12789142 12789156 12789157 12789158 12789160 12789161 12789178 12789179 12789180 12789181 12789200 12789201 12789203 12789204 12789222 12789223 12789224 12789225 12789235 12789237 12789238 12789254 12789255 12789256 12789258 12789276 12789278 12789279 12789280 12789281 12789303 12789304 12789305 12789306 12789307 12789315 12789316 12789317 12789318 12789319 12789334 12789335 12789336 12789337 12789338 12789350 12789351 12789352 12789353 12789354 12789368 12789369 12789371 12789372 12796287 12796413 12796444 12796448 12796451 12796465 12796466 12796470 12796487 12796506 12796510 12796530 12796551 12796555 12796560 12796561 12796564 12796567 12796595 12796641 12796644 12796647 12796648 12796659 12796661 12796722 12796741 12796744 12796847 12796592 12770982 12772644 12778584 12806228 12806264 12811249 12817214 12826924 12827431 12828197 12828771 12833553 12834704 12836383 12823862 12843451 12845760 12845639 12846335 12846359 12848030 12848042 12848058 12848064 12848098 12848190 12848192 12848203 12848220 12848233 12848251 12848264 12848282 12848308 12848321 12848323 12850418 12852390 12856359 12861589 12860667 12864404 12865293 12865129 12865586 12866474 12868223 12869887 12874644 12874770 12875100 12875356 12876975 12877040 12877126 12877787 12877827 12877922 12878194 12878243 12882243 12882530 12882698 12882733 12883064 12883070 12883242 12883248 12883273 12883284 12883330 12883339 12887339 12887340 12887349 12887374 12887375 12887383 12887385 12887386 12887405 12887461 12887466 12887451 12887486 12887498 12887500 12887513 12887517 12887522 12887524 12887527 12887532 12887536 12887539 12887542 12887543 12887546 12887549 12887550 12887551 12887552 12887570 12887590 12887610 12887611 12887612 12887613 12887614 12887615 12887616 12887617 12887619 12887634 12887662 12887663 12887664 12887665 12887666 12887667 12887668 12887669 12887670 12887671 12887712 12887714 12887715 12887716
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