| Class 2 Device Recall B Braun Thermodilution Right Heart Catheters |  |
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
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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
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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 |
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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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