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U.S. Department of Health and Human Services

Class 2 Device Recall Combiset Blood Line with BVM

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  Class 2 Device Recall Combiset Blood Line with BVM see related information
Date Initiated by Firm August 29, 2013
Date Posted November 08, 2013
Recall Status1 Terminated 3 on February 11, 2021
Recall Number Z-0185-2014
Recall Event ID 65739
510(K)Number K070049  
Product Classification Hemodialysis system for home use - Product Code ONW
Product Combiset Blood Line with BVM for Hemodialysis use
Catalog Number: 03-2965-9.

Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Code Information All lot codes
Recalling Firm/
Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact
Manufacturer Reason
for Recall
Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
FDA Determined
Cause 2
Labeling design
Action Fresenius issued a Field Notification Letter dated 8/29/13 to Patient Clinics/ associated at home patients and provides additional detail instructions to ensure the connection to the transducer protector bloodline female luer interface is secure. This field advisory notice sent by Certified Mail, Return Receipt Requested. Accounts requested to return both the receipt and the completed reply form (enclosed) to confirm receipt of the notice. If you have any questions regarding this field advisory, please contact FMCNA Customer Service Team at 1-800-323-5188. Customer Service will be available Monday-Friday 7am-6pm CST.
Quantity in Commerce 24,202 cases
Distribution Worldwide Distribution-USA (nationwide) and the country of Canada.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ONW and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA