Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and…
Medical device recall Z-1739-2022. Published in FDA’s Enforcement Report on Sep 21, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 21, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 595 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
595 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,992 characters
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…
FDA’s list runs to 5,904 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 26, 2022.
- FDA classified it on Sep 14, 2022.
- FDA’s Enforcement Report published it on Sep 21, 2022.
- FDA terminated it on May 31, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Isopure Corp, of Louisville, KY.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,904 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.