Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1770-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 Vivonic Part Number: G02000966-US

Product Classification:

Class II

Date Initiated: June 21, 2022

Date Posted: September 28, 2022

Recall Number: Z-1770-2022

Event ID: 90757

Reason for Recall:

Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured

Status: Ongoing

Product Quantity: 6 units

Code Information:

UDI: (01)4251285200234(11)200422(21)0CHS3987 (01)4251285200234(11)200526(21)0CHS4108 (01)4251285200234(11)210623(21)1CHS5372 (01)4251285200234(11)210707(21)1CHS5405 (01)4251285200234(11)190305(21)9CHS2881 (01)4251285200234(11)190529(21)9CHS3090 Serial Numbers: 0CHS3987 0CHS4108 1CHS5372 1CHS5405 9CHS2881 9CHS3090

Distribution Pattern:

US Nationwide distribution in the states of AZ, CA, DC, FL, GA, IN, MA, NV, NY, PA, TX.

Voluntary or Mandated:

Voluntary: Firm initiated