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U.S. Department of Health and Human Services

Class 2 Device Recall Conductivity Sensors utilized on Dialog and Dialog Hemodialysis Systems

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  Class 2 Device Recall Conductivity Sensors utilized on Dialog and Dialog Hemodialysis Systems see related information
Date Initiated by Firm January 28, 2022
Create Date April 15, 2022
Recall Status1 Open3, Classified
Recall Number Z-0872-2022
Recall Event ID 89784
510(K)Number K083460  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be used as spare parts for the following dialysis machines: 710200L (UDI 04046963686345), 710200S
(UDI 04046964285608), 710200U (UDI 04046964285615), 710200K (UDI 04046963686338), 710500L (UDI Not
applicable) and 710500K (UDI Not applicable).
Code Information Lots 4/21 and 5/21
Recalling Firm/
Manufacturer		 B Braun Medical Inc
824 12th Ave
Bethlehem PA 18018-3524
For Additional Information Contact B. Braun Avitum Technical Services
800-621-0445
Manufacturer Reason
for Recall		 Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on whether the dialysis machine is equipped with a Dialysis Fluid filter.
FDA Determined
Cause 2		 Process control
Action On February 17, 2022, the firm, B.Braun Medical Inc., mailed out Recall Customer Notification Letters to affected consignees. Distributors should notify affected customers. Customers should identify any affected products within the spare parts inventory of their facility, cease use, and quarantine the product. Do not destroy any affected product. If any machine exhibited repeated Alarm Code 1026 - "UF balance? Air leakage in dialyzer coupling" alarms, customer should discontinue therapy on the device and immediately quarantine the machine until it can be inspected and any impacted sensors replaced. Customers should inspect ALL Dialog+ and Dialog+ Evolution dialysis machines in their facility which may have been serviced with potentially impacted sensors. Once the firm receives the customer acknowledgement form, a representative will contact the customer on how to return impacted sensors and/or to schedule a time to inspect equipment. Customers with questions should contact B. Braun Avitum Technical Services at 1-800-21-0445.
Quantity in Commerce 80
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KDI and Original Applicant = B. BRAUN AVITUM AG
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