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U.S. Department of Health and Human Services

Class 2 Device Recall Small bore TPort Extension Set with Female Luer Lock Connector and Male Luer Lock TPort with Ultra

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  Class 2 Device Recall Small bore TPort Extension Set with Female Luer Lock Connector and Male Luer Lock TPort with Ultra see related information
Date Initiated by Firm September 17, 2008
Date Posted October 24, 2008
Recall Status1 Terminated 3 on May 05, 2009
Recall Number Z-0199-2009
Recall Event ID 49565
510(K)Number K955585  
Product Classification Intravascular Administration Set - Product Code FPA
Product Smallbore T-Port Extension Set with Female Luer Lock Connector and Male Luer Lock T-Port with Ultrasite Injection Site 5 in. The product is shipped 100 units per carton.
Code Information Item number 474515. Lot number 0061014615 exp 6/30/2013
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		 Product was assembled incorrectly and connected to the wrong part.
FDA Determined
Cause 2		 Employee error
Action The recalling firm issued an Urgent - Medical Device Recall letter dated 9/17/08 to the distributors informing them of the problem and the need to return the product. The letter states that further distribution of the product should be immediately discontinued. Utilizing the "Product Removal Acknowledgement" form, customers should combine their inventory with the inventories reported by their customers and record them on the form. If affected products and associated lot numbers are currently in their possession, customers should call Customer Support Department to arrange for shipping and replacement product. A Customer Support Rep will provide instructions for handling affected product.
Quantity in Commerce 3900 units
Distribution Nationwide Distribution --- including states of CA, FL, NC, NJ, and TX.
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 = FPA and Original Applicant = B. BRAUN MEDICAL, INC.
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