| 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-0997-05 |
Recall Event ID |
32177 |
510(K)Number | K822806 K832287 K841639 |
Product Classification |
Catheter, Flow Directed - Product Code DYG
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Product | Right Heart Catheter Product Line:
Catalog Number 601261-----WP605P Wedge Press Cath. |
Code Information |
Catalog Number: 601261. Lot Number, Exp Date: 0060461139, 5/31/05; 0060468252, 6/30/05; 0060484327, 7/31/05; 0060490856, 8/31/05; 0060534557, 12/31/05; 0060541502, 1/31/06; 0060558248, 2/28/06; 0060561935, 3/31/06; 0060565937, 4/30/06; 0060572444, 4/30/06; 0060577415, 5/31/06; 0060708815, 6/30/06; 0060710255, 7/31/06; 0060733103, 12/31/06; 0060743198, 1/31/06. |
Recalling Firm/ Manufacturer |
B. Braun Medical, Inc. 901 Marcon Blvd Allentown PA 18109-9512
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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 | 93 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 |
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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 = DYG
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