Date Initiated by Firm | September 01, 2020 |
Create Date | October 13, 2020 |
Recall Status1 |
Terminated 3 on January 20, 2021 |
Recall Number | Z-0098-2021 |
Recall Event ID |
86410 |
510(K)Number | K133829 |
Product Classification |
Subsystem, water purification - Product Code FIP
|
Product | AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies.
AquaBplus 1500 - Typ USA - 3 x 208V / 60Hz -Fresenius Part Number: 24-1500-1
AquaBplus B2 2000 / B1 2500 (Bplus DUO 2000) - 3 x 208V / 60Hz- Fresenius Part Number: 24-2000-0 |
Code Information |
9BDS1515 08D51544 OBDS1596 OBPS2864 9BDS1529 OBDS1545 OBPS2799 OBPS2884 9BPS2735 OBDS1551 OBPS2800 OBPS2903 9BPS2767 08D51590 OBPS2810 |
Recalling Firm/ Manufacturer |
Fresenius Medical Care Holdings, Inc. 920 Winter St Bld 950 Waltham MA 02451-1521
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For Additional Information Contact | Fresenius Medical Care Technical Service 800-553-1109 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | Process control |
Action | Fresenius Medical Care issued letter dated 9/1/20 stating reason for recall, health risk and action to take: A Fresenius Medical Care Renal Therapies Group Water Systems Service Specialist will be contacting you to schedule an appointment to check the connection and replace if necessary.
In the meantime, we ask that you do not perform any repairs or maintenance on the machine and wait for your scheduled service date. For questions or concerns or if you need service prior to your scheduled service date, please contact Technical Support Services at 888-553-1109. |
Quantity in Commerce | 15 units |
Distribution | US distribution to DE, NC, OK, PA, and TX. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = FIP
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