FDA Enforcement
Class II
Ongoing
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
Recall: Z-2141-2024
·
Reported June 19, 2024
Enforcement
- Recall Number
- Z-2141-2024
- Event ID
- 94676
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Fresenius Medical Care Holdings, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 19, 2024
- Initiation Date
- May 16, 2024
- Classification Date
- June 13, 2024
- Address
- 920 Winter St Bld 920, N/A, Waltham, MA, 02451-1521, United States
Description
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
Reason
Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply.
Code Info
UDI-DI: 04251285200357 Serial Numbers: 2AAV0003 2AAV0029 2AAV0037 3AAV0087
Distribution
US Nationwide distribution in the states of AL, IN, AK, WI.
Quantity
4 units