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U.S. Department of Health and Human Services

Class 3 Device Recall Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike

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  Class 3 Device Recall Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike see related information
Date Initiated by Firm December 10, 2007
Date Posted May 07, 2008
Recall Status1 Terminated 3 on October 28, 2008
Recall Number Z-1035-2008
Recall Event ID 46348
510(K)Number K952631  
Product Classification Hemodialysis kit - Product Code FJK
Product Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210513. The product is shipped 4 units per shipping carton. Hemodialysis kit, B. Braun Medical, Inc., Allentown, PA 18109
Code Information Lot Number 07F06 exp 2012-05 and Lot Number 07G09 exp 2012-06
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Boulevard
Allentown PA 18109-9512
For Additional Information Contact Kimberly Paris
610-266-0500 Ext. 2669
Manufacturer Reason
for Recall		 Faulty tubing does not prime machine as intended.
FDA Determined
Cause 2		 Process control
Action B. Braun Medical sent an Urgent Medical Device Reall letter dated 12/12/07. Customers were told to discontinue use of the tubing.
Quantity in Commerce 1544 units
Distribution 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 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 = FJK and Original Applicant = B. BRAUN MEDICAL, INC.
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