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
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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 |
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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 = FJK
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