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U.S. Department of Health and Human Services

Class 2 Device Recall Isopure

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  Class 2 Device Recall Isopure see related information
Date Initiated by Firm July 26, 2022
Date Posted September 13, 2022
Recall Status1 Terminated 3 on May 31, 2024
Recall Number Z-1739-2022
Recall Event ID 90739
510(K)Number K120005  
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
Product 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

Model: ACDS MD704262
Code Information 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 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-848253 AC-837561 AC-113027 AC-866165 AC-841319 AC-843858 AC-124395 AC-846631 AC-860241 AC-121277 AC-859415 AC-837874 AC-842723 AC114761 AC-119466 AC-866035 AC-116609 AC846655 AC-845308 AC-121233 AC-855936 AC07271504 AC-854886 AC-839635 AC-120802 AC-853547 AC-121266 AC-834167 AC-840902 AC-115839 AC-850044 AC-124634 AC-855688 AC-840896 AC-843867 AC01061504 AC-116415 AC-119433 AC-830862 AC-869208 AC-846664 AC-858010 AC-838173 AC-843324 AC-837419 AC--852733 AC-854880 AC-838143 AC-849825 AC-121255 AC-838740 AC- 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 AC-846658 AC-836209 AC-113554 AC-864699 AC16181206 AC-844976 AC-842283 AC-854216 AC-842143 AC-116271 AC-835851 AC-861615 AC-839310 AC-839626 AC-865549 AC-865546 AC-849209 AC-838749 AC-841310 AC-834171 AC-856370 AC-840412 AC-856361 AC-825275 AC04241504 AC-862973 AC01121402 AC-851212 AC-121307 AC-830812 AC-836223 AC-841594 AC-848998 AC-836216 AC-834645 AC-835752 AC-844972 AC-842017 AC-841080 AC-841304 AC-825264 AC-867957 AC-115726 AC-829240 AC-858013 AC-118569 AC-121755 AC-125017 AC-116282 AC-862219 AC-858004 AC-867630 AC-861277 AC-867945 AC05271403 AC-830842 AC-859834 AC-857066 AC-854895 AC-839212 AC-123924 AC-862961 AC-839484 AC-120791 AC-847183 AC08271504 AC-867942 AC-867948 AC-846637 AC-851505 AC-843363 AC05051204 AC-834651 AC-123274 AC-830188 AC-861603 AC-119444 AC-867309 AC-866162 AC-114609 AC-853482 AC-857054 AC-855697 AC-852748 N/A 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 AC-846214 AC853523 AC-841597 AC-853544 AC-837571 AC-852739 AC-862528 AC-853194 AC-854219 AC114909 AC-123957 AC-847437 AC-860579 AC-842726 AC-847752 AC-850038 AC11301410 AC-848643 AC-116342 AC-860208 AC-118670 AC-839629 AC-847180 AC-825330 AC-860582 AC-855691 AC-867621 AC-860576 AC-862949 AC-862964 AC-850047 AC-825286 AC-848355 AC-847882 AC13301504 AC-836754 AC-836734 AC-862967 AC-845317 AC-852100 AC-115737 AC-117133 AC-122776 AC15311205 AC-121244 AC-853532 AC-847885 AC-114586 AC-866729 AC-843855 AC-825242 AC-846646 AC-860250 AC-121288 AC-841825 AC-837864 AC-842729 AC114574 AC-119455 AC-865543 AC-117069 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- 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 AC-844974 AC-841822 AC-840899 AC-841307 AC-825297 AC-867951 AC115783 AC-829229 AC-857995 AC-122774 AC-124601 AC-116404 AC-862213 AC-858001 AC-867624 AC-865088 AC-861594 AC-831698 AC-857063 AC-839319 AC-124428 AC-862955 AC-839487 AC-120813 AC09281504 AC-867762 AC-867768 AC-846211 AC-848364 AC06051204 AC-834658 AC-123136 AC-861600 AC-119488 AC-867486 AC-866723 AC-116353 AC-853197 AC-857045 AC-852742 AC-118170 AC-835807 AC-852085 AC-857057 AC-852538 AC-835774 AC-853550 AC-846220 AC-843099 AC-844131 AC-845019 AC-845519 AC-844140 AC-862519 AC-862525 AC-860244 AC-856085 AC-864690
Recalling Firm/
Manufacturer		 Isopure Corp
11851 Plantside Dr
Louisville KY 40299-6328
For Additional Information Contact Tracy Hardin
502-907-6652
Manufacturer Reason
for Recall		 Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching
FDA Determined
Cause 2		 Device Design
Action Isopure initiated contact via telephone on 7/26/22 followed by Emails to consignees. .Letter states reason for recall, health risk and action to take: 1. Refer to Distribution List of ACDS units installed. 2. Perform an inspection of the ACDS device, associated wiring, cabling and cord. Provide a photograph if damage is found during inspection. 3. Video links are included in the inspection packet of the Isopure ACDS Instructions for Electrical Review and Preventive Maintenance of the ACDS and proper use of a torque screwdriver as a guide to inspecting electrical connections WI-50602. Please follow these guidance documents. Adhere to all safety information provided. 4. Fill out the Acknowledgement and Inspection Form upon completion of the inspection. Return the Acknowledgment form back to Isopure to Quality@isopure.com by September 30, 2022. 5. Always replace any depleted or blown fuses with the correct type and correct rating. 6. Follow the recommended preventive maintenance schedule for the device (refer to LA704262 ACDS Acidified Concentrate Distribution and Storage System User Manual). 7. Contact Isopure Customer/Technical Support at 502-967-7873 with any questions or concerns. Refer to: How -To-Video- Instructions ACDS Preventive Maintenance Instructions https://vimeo.com/732224767
Quantity in Commerce 595 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPO and Original Applicant = ISOPURE CORP.
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