Reported Sep 21, 2022 · Terminated

Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with…

Isopure Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Isopure Corp · 11851 Plantside Dr · Louisville, KY · 40299-6328

Is this the product you have?

Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment
of Hemodialysis patients ModelACDS MD704262

Lot codes and dates: Unique Device Identifier (UDI-DI) - 00852456007092
Serial Numbers
AC-869226
AC-869232
AC-869223
AC-867759
AC-867306
AC-862958
AC-862507
AC-867765
AC-866732
AC-865085
AC-857327
AC-825341
AC-02041204
AC-828320
AC-843375
AC-866726
AC-121340
AC21041212
AC-835763
AC-847755
AC-119356
AC-864675
AC-867939
AC-852751
AC-118472
AC06241504
AC-844137
AC-830206
AC-123056
AC-857333
AC-123169
AC-124590
AC-117928
AC-845510
AC-841313
AC-851496
AC-851502
AC-849420
AC-846640
AC-848995
AC-861609
AC-114598
N/A
111 of 111 codes
AC-117041
AC-867933
AC-825253
AC-834163
AC-849423
AC-854222
AC-854213
AC03041204
AC-846217
AC853485
AC-852090
AC-841600
AC-853559
AC-838743
AC-836202
AC-852745
AC-862513
AC-853730
AC-853535
AC-113494
AC-123880
AC-847434
AC-860585
AC-842280
AC-847758
AC-849828
AC10301410
AC-848634
AC-116620
AC-860205
AC-118659
AC-839632
AC-847177
AC-825308
AC-861274
AC-837654
AC-831676
AC-857330
AC-866735
AC-860588
AC-863236
AC-863239
AC-850162
AC-828331
AC-848358
AC-847888
AC12291504
AC-836714
AC-836724
AC-864696
AC-844134
AC-852535
AC-115347
AC-113451
AC122440
AC-117799
AC14311205
AC-121318
AC-857992
AC-853529
AC-
144 of 144 codes
850159
AC-835829
AC-123891
AC-843372
AC-830688
AC-123147
AC-847891
AC-118181
AC-853538
AC-848361
AC-856367
AC-844970
AC02091504
AC-838020
AC-117342
AC-864687
AC-858844
AC-857048
AC-857060
AC-828689
AC-843139
AC-122217
AC-862976
AC-864678
AC-123847
AC-846634
AC-829065
AC03051311
AC-118980
AC07061406
AC-841074
AC-834162
AC-124235
AC-843369
AC-843360
AC-869217
AC-117052
AC-837664
AC-838050
AC-122765
AC-860253
AC-844425
AC-859840
AC-122743
AC07031205
AC09111205
AC10281504
AC-854228
AC-862210
AC03101404
AC-836744
AC-862522
AC-852541
AC-115794
AC-851508
AC-867954
AC-848640
AC-862222
AC-830802
AC-867300
N/A
121 of 121 codes
AC-117144
AC-835840
AC-852095
AC-857051
AC-852544
AC-835741
AC-835785
AC-853553
AC-846661
AC-843061
AC-843870
AC-845010
AC-843096
AC-845516
AC-869235
AC-844422
AC-862531
AC-862534
AC-859837
AC-854892
AC-828700
AC-849160
AC-864693
AC-869211
AC-869205
AC-869229
AC-867303
AC-862516
AC-757936
AC-866168
AC-865555
AC-857324
AC-828342
AC-828353
AC-843861
AC-866038
AC-121753
AC22041212
AC-836764
AC-847761
AC-118580
AC-764672
AC-852736
AC-123902
AC-123935
AC-117331
AC-845513
AC-841316
AC-851499
AC-849426
AC-846649
AC-849157
AC-861606
AC-114772
AC-117155
AC-867930
AC-830197
AC-849831
AC-853556
AC04041204
N/A
AC-845311
AC-121764
AC11291504
AC-120822
AC-854889
AC-834161
AC-841077
AC-115850
AC-850041
AC-825319
AC-855700
AC-840905
AC-843864
AC-119477
AC-8231720
AC-867771
AC-847186
AC-838040
AC-843142
AC-853200
AC-854883
AC-838153
AC-849834
AC-838260
AC-
848370
AC-835796
AC-123913
AC-843357
AC-830677
AC-123968
AC-848256
AC-117917
AC-853526
AC-848367
AC-845016
AC03201504
AC-838030
AC-117535
AC-864681
AC-858841
AC-855694
AC-829073
AC-83188
AC-
118 of 118 codes
117546
AC-862952
AC-863233
AC-124579
AC-846652
AC-829057
AC04051311
AC-118991
AC-841071
AC-834168
AC-123092
AC-843354
AC-843366
AC-117166
AC-838270
AC-124236
AC-857911
AC-845314
AC-859831
AC-122754
AC08031205
AC10111205
AC14301504
AC-854225
AC-862216
AC04101404
AC-837425
AC-862510
AC-115358
AC-850598
AC-867774
AC-848637
AC-861612
AC-830872
AC-846643
AC-864684
AC17181206
AC-844968
AC-842720
AC-853541
AC-842140
AC-835818
AC-862225
AC-839313
AC-840409
AC-865552
AC-849206
AC-834188
AC-838746
AC-856364
AC-825363
AC05241504
AC-863242
AC02121402
AC-830832
AC-836195
AC-841819
AC-836188
AC-834638
AC-835730
Amount recalled: 595 units

Where it was sold

Nationwide

Why it was recalled

Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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