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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 25, 2005
Date Posted July 16, 2005
Recall Status1 Terminated 3 on December 14, 2006
Recall Number Z-1008-05
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 604103-------------T047(97) 427D4036I.
Code Information Catalog Number 604103 Lot Number, exp.Date: 0060454893, 4/30/05; 0060467329, 6/30/05'' 0060486208, 7/31/05; 0060486209, 7/31/05; 0060491077, 9/30/05; 0060510922, 11/30/05; 0060514276, 10/31/05; 0060537036, 12/31/05; 0060541575, 2/28/06; 0060551166, 2/28/05; 0060568862, 5/31/06; 0060570914, 5/31/06; 0060579875, 5/31/06; 0060710236, 8/31/06; 0060716577, 8/31/06; 0060721776, 9/30/06; 0060721777, 8/31/06; 0060721778, 10/31/06; 0060726790, 11/30/06.
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 231 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
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