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U.S. Department of Health and Human Services

Class 2 Device Recall B. Braun Introcan Safety IV Catheter

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 Class 2 Recall
B. Braun Introcan Safety IV Catheter
see related information
Date Posted December 21, 2013
Recall Status1 Terminated on October 08, 2014
Recall Number Z-0559-2014
Recall Event ID 66535
Premarket Notification
510(K) Numbers
K020785  K021094 
Product Classification Introducer, Catheter - Product Code DYB
Product B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of vascular access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into vascular system.
Code Information lot no. 3C30258317
Recalling Firm/
Manufacturer
B. Braun Medical, Inc.
901 Marcon Boulevard
Allentown, Pennsylvania 18109-9512
For Additional Information Contact Customer Support
610-596-2870
Manufacturer Reason
for Recall
One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries.
FDA Determined
Cause 2
MISBRANDING: Labeling False and Misleading
Action B. Braun sent an Urgent Medical Device Recall Notification letter dated September 27, 2013 to all affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to utilize the attached "Product Removal Acknowledgement Form" to record the number of individual units in their inventory and fax the completed form to 610-848-1197. To ensure proper credit for affected product, customers were instructed to return the product to B. Braun Medical Inc. For questions contact Customer Support Department at 800-227-2862.
Quantity in Commerce 55,200 units
Distribution USA Nationwide Distribution including Puerto Rico.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = B. BRAUN MEDICAL, INC.
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