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U.S. Department of Health and Human Services

Class 2 Device Recall B.Braun Celsite

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 Class 2 Recall
B.Braun Celsite
see related information
Date Posted June 27, 2011
Recall Status1 Terminated on July 06, 2012
Recall Number Z-2671-2011
Recall Event ID 58718
Premarket Notification
510(K) Numbers
K061424  K952548  K962230  K993024 
Product Classification Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Product B. Braun Celsite® Venous Access Ports , Distributed by Aesculpa Inc. Model ST301, ST305V, ST301G, ST501G and ST315 Reference # Model # 04430425 ST301 04430095 ST305V 04433823 ST301G 04437025 ST501G 04436725 ST315
Code Information Reference # Model # Lot # 04430425 ST301 J313196U 04430095 ST305V J312177U 04433823 ST301G J313197U K021193U 04437025 ST501G J312178U 04436725 ST315 J295789U
Recalling Firm/
Manufacturer
B. Braun Interventional Systems
14276 23rd Ave N
Plymouth, Minnesota 55447-4910
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The affected products contain the incorrect winged Surecan¿ needle accessory component in certain Celsite¿ Access Port package configurations. The winged Surecan¿ needle is used to deliver medications and fluids into implanted Celsite¿ Access Ports. Two winged Surecan¿ needle sizes are provided in Celsite¿ U.S. package configurations: 20G (PN 4058631) or 22G (PN 16006593A). A 20G or 22G needle
FDA Determined
Cause 2
DESIGN: Process Design
Action B.Braun Interventional Systems Inc, (BIS) sent a "Urgent Medical Device Recall" letter on April 16, 2011 to all affected customers. The letter described the problem and the product involved in the recall. Informed consignees that their local B.Braun Interventional System Inc Product Specialists will contact them with the specifics for return/replacement of the product upon return of qualified removed product. They also requested that a Celsite® Access Port Patient Implant Form be filled out for each patient implanted with one of the Celsite® Access Ports from the affected lots. This Form to be provided to them by their local BIS Product Specialist. For additional information contact 800 523-9676 x4459.
Quantity in Commerce 83
Distribution NY, ND, OK ,PA
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 = LJT and Original Applicant = AESCULAP, INC.
510(K)s with Product Code = LJT and Original Applicant = B. BRAUN MEDICAL, INC.
510(K)s with Product Code = LJT and Original Applicant = B. BRAUN OF AMERICA, INC.
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