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U.S. Department of Health and Human Services

Class 2 Device Recall B Braun Thermodilution Right Heart Catheters

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  Class 2 Device Recall B Braun Thermodilution Right Heart Catheters see related information
Date Initiated by Firm June 05, 2007
Date Posted July 23, 2007
Recall Status1 Terminated 3 on October 31, 2007
Recall Number Z-1116-2007
Recall Event ID 38105
510(K)Number K832287  
Product Classification Heart Catheters - Product Code DYG
Product Thermodilution Right Heart Catheters, Catalog Numbers 604028 and 604165. The product is shipped 5 units per carton.-B. Braun Medical, Allentown, Pa.
Code Information Catalog numbers 604028: Lot numbers 60759210 exp 6/07, 60774338 exp 9/07, 60774339 exp 6/07, 60789198 exp 7/07, 60793228 exp 8/07, 60798079 exp 6/07, 60798080 exp 7/07, 60798858 exp 8/07, 60805581 exp 8/07, 60814631 exp 10/07, 60814632 exp 9/07, 60816722 exp 10/07, 60873702 exp 7/08, 60885381 exp 10/08, 60887358 exp 9/08, 60894377 exp 11/08, 60899729 exp 11/08, 60906657 exp 12/08, 60911647 exp 1/09, and 60916540 exp 3/09. --Catalog numbers 60416540: Lot numbers 60781356 exp 7/07 and 60798862
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Boulevard
Allentown PA 18109-9512
For Additional Information Contact Kimberly Paris
610-266-0500
Manufacturer Reason
for Recall		 Cracks at the Catheter Tip
FDA Determined
Cause 2		 Other
Action On 6/5/07, a Product Removal Notice was issued to the only distributor that received the product in Japan
Quantity in Commerce 4,695
Distribution International ONLY- 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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