FDA Device recall Z-1739-2022

Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intend…

FDA Device
Class II
terminated
Published 2022-09-21

On 2022-09-21 the FDA classified a Class II recall of Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intend… by Isopure, citing acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1739-2022
Classification	Class II
Status	terminated
Initiated	2022-07-26
Published	2022-09-21
Last updated	2026-09-13 11:56 UTC
Company	Isopure
Distribution	US

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

Reason

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

Identifiers

code_info	Unique Device Identifier (UDI-DI) - 00852456007092 Serial Numbers: AC-869226 AC-869232 AC-869223 AC-867759 AC-867306 AC… 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

code_info

Unique Device Identifier (UDI-DI) - 00852456007092 Serial Numbers: AC-869226 AC-869232 AC-869223 AC-867759 AC-867306 AC…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1739-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.