Recall Z-1769-2022— Fresenius Medical Care Holdings, Inc.
Class II · Ongoing
Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2022-06-21. It names one FDA 510(k) clearance: K143617. Product: AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US. Reason: Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured.
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-21
- Firm location
- Waltham, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US
Reason for recall
Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
Data sourced from openFDA. This site is unofficial and independent of the FDA.