US AquaA 900H-Typ USA-3 x 208v-Intended for the recall
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…
Why was US AquaA 900H-Typ USA-3 x 208v-Intended for the recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 04251285200357 Serial Numbers: 2AAV0003 2AAV0029 2AAV0037 3AAV0087
- Product
- 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…
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 4 units
- Distribution
- US Nationwide distribution in the states of AL, IN, AK, WI.
- Recall date
- June 19, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)