Recall Z-1464-2022— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-1464-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-16

Class II · Ongoing

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2022-06-16. It names one FDA 510(k) clearance: K143617. Product: AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US. Reason: Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock.

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-06-16
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K143617 — AquaC UNO HVivonic GmbH·cleared 2015-10-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

Reason for recall

Internal ethernet cable may be misaligned, the cable jacket (insulation) could become compromised due to high temperature and result in the internal ethernet cable conducting electrical current to the ethernet port on the outside of the device), potentially harming service technicians and/or other authorized operators. If the ethernet port on the device is touched or manipulated, there is a risk of electrical shock

Data sourced from openFDA. This site is unofficial and independent of the FDA.