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 MD
Check against the official notice below — it lists the full affected range.
Isopure Corp is recalling approximately 595 units of the Isopure Acidified Concentrate Distribution System (ACDS) with remote fill, a device used in hemodialysis facilities. The devices pose a potential electrical safety hazard that may result in electric shock or arcing. The recalled units were distributed nationwide and are identified by the Unique Device Identifier (UDI-DI) 00852456007092, with a comprehensive list of specific serial numbers provided in the recall notice.
The record does not specify a remedy or any action consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching
Reason for recall: Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching Distribution: US Nationwide distribution. Quantity: 595 units Lot/code info: 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-
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.