Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recallsee related information
Date Initiated by FirmMay 25, 2005
Date PostedJuly 16, 2005
Recall Status1 Terminated 3 on December 14, 2006
Recall NumberZ-1005-05
Recall Event ID 32177
510(K)NumberK822806 K832287 K841639 
Product Classification Catheter, Flow Directed - Product Code DYG
ProductRight 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 ContactLori 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
ActionThe firm sent out recall notification letters to the Directors of Materials Management on 5/27/2005.
Quantity in Commerce580 units
DistributionProduct was distributed to distributors and hospitals nationwide. Also, the products were distributed to Germany and Japan.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DYG
-
-