|
Class 2 Device Recall |
|
Date Initiated by Firm |
May 25, 2005 |
Date Posted |
July 16, 2005 |
Recall Status1 |
Terminated 3 on December 14, 2006 |
Recall Number |
Z-1005-05 |
Recall Event ID |
32177 |
510(K)Number |
K822806 K832287 K841639
|
Product Classification |
Catheter, Flow Directed - Product Code DYG
|
Product |
Right Heart Catheter Product Line: Catalog Number 604037------T047-02 0427D10061. |
Code Information |
Catalog Number 604037. Lot Number, Exp. Date: 0060460638, 5/31/05; 0060471048, 6/30/05; 0060486204, 7/37/05; 0060490913, 8/31/05; 0060510913, 11/30/05; 0060514285, 10/31/05; 0060527620, 11/30/05; 0060537029, 12/31/05; 0060541565, 1/31/06; 0060551161, 2/28/06; 0060558495, 2/28/06; 0060568861, 3/31/06; 0060579881, 5/31/06; 0060714560, 9/30/06; 0060716589, 8/31/06; 0060726783, 10/31/06; 0060733295, 10/31/06; 0060738519,11/30/06; 0060741037, 12/31/06; 0060745654, 12/31/06; 0060746780, 1/31/06. |
Recalling Firm/ Manufacturer |
B. Braun Medical, Inc. 901 Marcon Blvd Allentown PA 18109-9512
|
For Additional Information Contact |
Lori Sands 856-751-2080
|
Manufacturer Reason for Recall |
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
|
FDA Determined Cause 2 |
Other |
Action |
The firm sent out recall notification letters to the Directors of Materials Management on 5/27/2005. |
Quantity in Commerce |
580 units |
Distribution |
Product was distributed to distributors and hospitals nationwide. Also, the products were distributed to Germany and Japan. |
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 = DYG and Original Applicant = NOVA MEDICAL SPECIALTIES
|
|
|
|