Recalls affecting Louisiana

FDA has not published a risk classification for this recall yet.

Recall #:

86697

Lot/product code:

Model: V60 Part Number: 1076709 V60 Ventilator, JAPAN OPT: CFLEX,AVAPS,AT+  Serial Numbers: 100058561 100058562 100058565 100058572 100058573 100058574 100058576 100058835 100058840 100058844 100058845 100058846 100058902 100058903 100058904 100058905 100058906 100058908 100058911 100058914 100058917 100058968 100058970 100058971 100058975 100058977 100058990 100058991 100058994 100058997 100058999 100059002 100059149 100059153 100059163 100059239 100059248 100060123 100060124 100060214 100060215 100060216 100060219 100060220 100060222 100060229 100060232 100060234 100060236 100060239 100060328 100060329 100060330 100060331 100060339 100060340 100060341 100060344 100060345 100060346 100060347 100060388 100060389 100060398 100060400 100060402 100060404 100060406 100060407 100060409 100060410 100060416 100060476 100060483 100060484 100060486 100060487 100060488 100060490 100060491 100060492 100060494 100060496 100064705 100064706 100064707 100064710 100064712 100064830 100064837 100065342 100065346 100065347 100065351 100065353 100065354 100065355 100065356 100065358 100065359 100065360 100065361 100065362 100067432 100067443 100067445 100067447 100067449 100067536 100068184 100068356 100068357 100069968 100070232 100070233 100070234 100070236 100070305 100070307 100070308 100070309 100070396 100070397 100070399 100070400 100070401 100070403 100070404 100070405 100070406 100070407 100070410 100070411 100070412 100070475 100070478 100070479 100070481 100070483 100070485 100070486 100070488 100070489 100070490 100070493 100070495 100070769 100070773 100070775 100070779 100070782 100070856 100070857 100070934 100070970 100070978 100071069 100071076 100071384 100071385 100071387 100071389 100071391 100071392 100071398 100072410 100072411 100072413 100072493 100072593 100072600 100072602 100072603 100072604 100072608 100072675 100072680 100072689 100072694 100074196 100074198 100074204 100074205 100074208 100075092 100075093 100075094 100075097 100075098 100075102 100075103 100075105 100075106 100075165 100075166 100075167 100075168 100075169 100075170 100075171 100075172 100075173 100075174 100075175 100075176 100075177 100075178 100075179 100075180 100075181 100075182 100075183 100075184 100075185 100075186 100075187 100075188 100075294 100075296 100075297 100075298 100075299 100075300 100075301 100075302 100075303 100075304 100075307 100075308 100075309 100075367 100075368 100075372 100075373 100075375 100075377 100075379 100075380 100075382 100078057 100078058 100078059 100078122 100078130 100078131 100078133 100078134 100078135 100078136 100078137 100078138 100078139 100078141 100078142 100078143 100078144 100078146 100078147 100078148 100078149 100078150 100078151 100078152 100078153 100078154 100078155 100078260 100078261 100078262 100078263 100078264 100078265 100078267 100078268 100078270 100078271 100078272 100078273 100078274 100078275 100078276 100078299 100078300 100078301 100078303 100078304 100078305 100078306 100078307 100078308 100078310 100078311 100078312 100078314 100078315 100078316 100078317 100078361 100078363 100078373 100078375 100078376 100078377 100078378 100078380 100078381 100079713 100080234 100080235 100080238 100080270 100080272 100080273 100080274 100080278 100080279 100080280 100080283 100080284 100080287 100080288 100080293 100080296 100080538 100080539 100080646 100080648 100080655 100080703 100080705 100080707 100080710 100080715 100080719 100080720 100080730 100080732 100080735 100080737 100080851 100083533 100083565 100083602 100083812 100083814 100083818 100083826 100083827 100083829 100084956 100084958 100084959 100085081 100085083 100085088 100085091 100085094 100085096 100085097 100085098 100085251 100085335 100085341 100085382 100085384 100085390 100085391 100085392 100085393 100085394 100085396 100085400 100085402 100085403 100085404 100085489 100086237 100086889 100086895 100086899 100086903 100087014 100087015 100087018 100087024 100087026 100087030 100087031 100087048 100087051 100087055 100087056 100087160 100087341 100087355 100087359 100087461 100087467 100087469 100087476 100087480 100087481 100087483 100087486 100087601 100087605 100087610 100087615 100087686 100087690 100087694 100087700 100090529 100090530 100090533 100090534 100090535 100090537 100090538 100090539 100090540 100090541 100090542 100090543 100090544 100090546 100090548 100090549 100090551 100090554 100090555 100090556 100090653 100090655 100090656 100090657 100090659 100090660 100090661 100090662 100090663 100090664 100090666 100090669 100090671 100090673 100090675 100090676 100090678 100090679 100090783 100090785 100090790 100090791 100090795 100090802 100090806 100090807 100090912 100090913 100090915 100090918 100090920 100091021 100091261 100091273 100091377 100091378 100091379 100091394 100091397 100091399 100091403 100091720 100091722 100091723 100091724 100091726 100091728 100091729 100091730 100091732 100091735 100091737 100091738 100091739 100091743 100091745 100091818 100091841 10009184… (truncated, 37611 characters total — see the official FDA record for the full value)

Recalling firm:

Respironics California, LLC

FDA has not published a risk classification for this recall yet.

Recall #:

86847

Lot/product code:

Serial numbers CU4.0-01062 CU4.0-01063 CU4.0-01066 CU4.0-01068 CU4.0-01069 CU4.0-01070 CU4.0-01072 CU4.0-01073 CU4.0-01074 CU4.0-01076 CU4.0-01078 CU4.0-01079 CU4.0-01081 CU4.0-01083 CU4.0-01084 CU4.0-01086 CU4.0-01088 CU4.0-01089 CU4.0-01090 CU4.0-01091 CU4.0-01093 CU4.0-01094 CU4.0-01095 CU4.0-01096 CU4.0-01097 CU4.0-01100 CU4.0-01101 CU4.0-01102 CU4.0-01103 CU4.0-01104 CU4.0-01106 CU4.0-01107 CU4.0-01108 CU4.0-01110 CU4.0-01113 CU4.0-01114 CU4.0-01115 CU4.0-01116 CU4.0-01117 CU4.0-01119 CU4.0-01121 CU4.0-01123 CU4.0-01124 CU4.0-01126 CU4.0-01127 CU4.0-01128 CU4.0-01129 CU4.0-01130 CU4.0-01131 CU4.0-01132 CU4.0-01133 CU4.0-01134 CU4.0-01135 CU4.0-01138 CU4.0-01141 CU4.0-01142 CU4.0-01143 CU4.0-01144 CU4.0-01146 CU4.0-01147 CU4.0-01149 CU4.0-01151 CU4.0-01152 CU4.0-01153 CU4.0-01154 CU4.0-01157 CU4.0-01158 CU4.0-01159 CU4.0-01160 CU4.0-01161 CU4.0-01162 CU4.0-01163 CU4.0-01164 CU4.0-01165 CU4.0-01166 CU4.0-01167 CU4.0-01170 CU4.0-01173 CU4.0-01174 CU4.0-01175 CU4.0-01176 CU4.0-01177 CU4.0-01178 CU4.0-01179 CU4.0-01185 CU4.0-01186 CU4.0-01191 CU4.0-01195 CU4.0-01198 CU4.0-01203 CU4.0-01205 CU4.0-01215 CU4.0-01231 CU4.0-01233 CU4.0-01234 CU4.0-01237 CU4.0-01239 CU4.0-01245 CU4.0-01248 CU4.0-01251 CU4.0-01252 CU4.0-01255 CU4.0-01268 CU4.0-01289 CU4.0-01292 CU4.0-01299

Recalling firm:

Boston Scientific Corporation

FDA has not published a risk classification for this recall yet.

Recall #:

90429

Lot/product code:

GTIN 00763000178178, Serial Numbers: RTK601865S, RTK601825S, RTK601828S

Recalling firm:

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA has not published a risk classification for this recall yet.

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC038 20NXAC032

Recalling firm:

Fresenius Medical Care Holdings, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC097  Additional affected lot as of 3/17/21: 20NXAC033

Recalling firm:

Fresenius Medical Care Holdings, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC070 20LXAC103 20NXAC021 20LXAC100 20LXAC026 20LXAC027 20LXAC028 20LXAC029 20LXAC065 20LXAC067 20LXAC071 20NXAC001 20NXAC019 20NXAC020 20NXAC029  Additional affected lots as of 3/17/21: 20LXAC103 20LXAC082 20LXAC025 20LXAC081 20LXAC083

Recalling firm:

Fresenius Medical Care Holdings, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC034 20LXAC069 20NXAC040

Recalling firm:

Fresenius Medical Care Holdings, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC031  Additional affected lots as of 3/17/21: 20NXAC004 20LXAC033 20NXAC003 20LXAC032

Recalling firm:

Fresenius Medical Care Holdings, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86855

Lot/product code:

Lot Numbers: 20NXAC034

Recalling firm:

Fresenius Medical Care Holdings, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC051

Recalling firm:

Fresenius Medical Care Holdings, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC032 20NXAC003

Recalling firm:

Fresenius Medical Care Holdings, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC056 20LXAC057 20NXAC038 20LXAC041 20LXAC055  Additional affected lots as of 3/17/21: 20NXAC013 20NXAC035

Recalling firm:

Fresenius Medical Care Holdings, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86855

Lot/product code:

Lot Numbers: 20NXAC005 20LXAC098 20NXAC037 20NXAC039  Additional affected lots as of 3/17/21: 20NXAC008 20LXAC063

Recalling firm:

Fresenius Medical Care Holdings, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC043 20LXAC044 20LXAC045 20LXAC059 20LXAC060 20LXAC079 20LXAC095 20NXAC026  Additional lots as of 3/17/21: 20LXAC078 20NXAC012 20LXAC058 20LXAC096 20NXAC011

Recalling firm:

Fresenius Medical Care Holdings, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC090 20NXAC044

Recalling firm:

Fresenius Medical Care Holdings, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC052  Additional affected lot as of 3/17/21: 20LXAC088

Recalling firm:

Fresenius Medical Care Holdings, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC061 20NXAC036 20LXAC062  Additional affected lots as of 3/17/21: 20LXAC099 20LXAC086 20NXAC014

Recalling firm:

Fresenius Medical Care Holdings, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC030 20LXAC084 20NXAC002 20LXAC014 20NXAC018

Recalling firm:

Fresenius Medical Care Holdings, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC042

Recalling firm:

Fresenius Medical Care Holdings, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC024 20LXAC072 20LXAC073 20LXAC085 20NXAC017 20NXAC030 20LXAC074 20LXAC023 20LXAC104  Additional affected lots as of 3/17/21: 20LXAC066 20LXAC089

Recalling firm:

Fresenius Medical Care Holdings, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC092 20NXAC006 20NXAC027

Recalling firm:

Fresenius Medical Care Holdings, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86855

Lot/product code:

Lot Numbers: 20LXAC048 20LXAC053 20LXAC047 20NXAC016 20LXAC094 20NXAC009 20LXAC049 20LXAC054 20NXAC025 20NXAC024  Additional Affected lots as of 3/17/21: 20LXAC076 20LXAC077 20LXAC091 20LXAC101 20NXAC010 20NXAC016

Recalling firm:

Fresenius Medical Care Holdings, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

86734

Lot/product code:

SMS ID / Serial Number  SMS20200126 41F41E7A3011, SMS20200182 41F41E7A5006, SMS20200184 41F41E7A5008, SMS20180073 41F41DD7C006, SMS20180068 41F41DD7C003, SMS20180075 41F41DD7C007, SMS20180349 41F41DD85007, SMS20180350 41F41DD85009, SMS20180351 41F41DD86007, SMS20180448 41F41DD88001, SMS20190308 41F41E798002, SMS20190335 41F41E799002, SMS20190383 41F41E79A010, SMS20200033 41F41E79B001, SMS20200034 41F41E79B005, SMS20200219 41F41E7A6012, SMS20200301 41F41E7A6051, SMS20200339 41F41E7A7006, SMS20190016 41F41DD88010, SMS20190138 41F41DD8B007, SMS20190268 41F41E797001, SMS20190307 41F41E798003, SMS20200211 41F41E7A6005, SMS20200232 41F41E7A6020, SMS20200236 41F41E7A6024, SMS20200244 41F41E7A6025, SMS20200245 41F41E7A6026, SMS20180141 41F41DD83007, SMS20190008 41F41DD88007, SMS20190009 41F41DD88008, SMS20200325 41F41E7A6055, SMS20180076 41F41DD81002, SMS20190212 41F41DD8C012, SMS20200059 41F41E7A1007, SMS20200212 41F41E7A6010, SMS20200279 41F41E7A6041, SMS20200324 41F41E7A7002, SMS20200332 41F41E7A7005, SMS20200332 41F41E7A7005, SMS20190129 41F41DD8A018, SMS20190213 41F41DD8C013, SMS20200095 41F41E7A2004, SMS20200087 41F41E7A2006, SMS20200088 41F41E7A2007, SMS20200116 41F41E7A3002, SMS20200117 41F41E7A3003, SMS20180205 41F41DD83023, SMS20180230 41F41DD84006, SMS20190171 41F41DD8C002, SMS20190045 41F41DD89003, SMS20180374 41F41DD87004, SMS20200159 41F41DD87004, SMS20190189 41F41DD8C008, SMS20180117 41F41DD82008, SMS20180096 41F41DD82009, SMS20180097 41F41DD82010, SMS20180185 41F41DD83019, SMS20200129 41F41E7A4002, SMS20200130 41F41E7A4003, SMS20200131 41F41E7A4004, SMS20200132 41F41E7A4005, SMS20200206 41F41E7A6004, SMS20180242 41F41DD84019, SMS20190076 41F41DD89010, SMS20190113 41F41DD8A009, SMS20190092 41F41DD89013, SMS20200208 41F41E7A6002, SMS20180066 41F41DD7C004, SMS20180067 41F41DD7C005, SMS20190367 41F41E799010, SMS20190075 41F41DD89009, SMS20200096 41F41E7A2005, SMS20200280 41F41E7A6042, SMS20200348 41F41E7A7004, SMS20180115 41E09E963008, SMS20180082 41F41DD81005, SMS20180245 41F41DD85003, SMS20190160 41F41DD8B014, SMS20200165 41F41E7A4016, SMS20200271 41F41E7A6035, SMS20180065 41F41DD7C002, SMS20180104 41F41DD82011, SMS20200021 41F41E79B003, SMS20200040 41F41E7A1006, SMS20200042 41F41E7A1001, SMS20200148 41F41DD81010,, SMS20180129 41F41DD83001, SMS20180130 41F41DD83002, SMS20180131 41F41DD83003, SMS20180132 41F41DD83004, SMS20180133 41F41DD83005, SMS20180158 41F41DD83008, SMS20180159 41F41DD83009, SMS20180177 41F41DD83015, SMS20180178 41F41DD83016, SMS20190344 41F41DD7C003, SMS20180261 41F41DD85005, SMS20180262 41F41DD85006, SMS20200043 41F41E7A1002, SMS20200044 41F41E7A1003, SMS20200067 41F41E7A1004, SMS20200055 41F41E7A1009, SMS20200062 41F41E7A1010, SMS20180206 41F41DD83026, SMS20180237 41F41DD84013, SMS20180238 41F41DD84014, SMS20190003 41F41DD88004, SMS20200240 41F41E7A6029, SMS20200241 41F41E7A6030, SMS20200078 41F41E7A6032, SMS20180077 41F41DD81001, SMS20180078 41F41DD81003, SMS20200022 41F41E79B004, SMS20200227 41F41E7A6016

Recalling firm:

Shimadzu Medical Systems

FDA has not published a risk classification for this recall yet.

Recall #:

86774

Lot/product code:

Catalog Number: K-ACT Lot Number: 1-19-K-ACT and 2-19-K-ACT

Recalling firm:

Helena Laboratories, Corp.

FDA has not published a risk classification for this recall yet.

Recall #:

86895

Lot/product code:

CareLinkTM Personal (MMT-7333) using CareLink Uploader (ACC-7350) UDI (GTIN/UPN): 00763000424121  CareLinkTM system (MMT-7350) using CareLink Uploader (ACC-7350) UDI (GTIN/UPN): 00763000424138

Recalling firm:

Medtronic Inc.