AquaBplus and AquaBplus B2 Water Purification System. recall
AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial…
Why was AquaBplus and AquaBplus B2 Water Purification System. recalled?
Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connections could become loose and may adversely affect the electrical safety of the products, potentially resulting in electrical shock to the Biomed Technician or clinic staff.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
9BDS1515 08D51544 OBDS1596 OBPS2864 9BDS1529 OBDS1545 OBPS2799 OBPS2884 9BPS2735 OBDS1551 OBPS2800 OBPS2903 9BPS2767 08D51590 OBPS2810
- Product
- AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial…
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 15 units
- Distribution
- US distribution to DE, NC, OK, PA, and TX.
- Recall date
- October 21, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)