Date Initiated by Firm |
December 10, 2007 |
Date Posted |
May 07, 2008 |
Recall Status1 |
Terminated 3 on October 28, 2008 |
Recall Number |
Z-1036-2008 |
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 7210517. The product is shipped 4 units per shipping carton. Hemodialysis kit, B. Braun Medical, Inc., Allentown, PA 18109 |
Code Information |
Lot Number 07G04 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 |
956 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.
|