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U.S. Department of Health and Human Services

Class 2 Device Recall B. Braun Stopcock Extension Set

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  Class 2 Device Recall B. Braun Stopcock Extension Set see related information
Date Initiated by Firm May 29, 2014
Date Posted July 09, 2014
Recall Status1 Terminated 3 on December 10, 2014
Recall Number Z-2022-2014
Recall Event ID 68546
510(K)Number K942988  
Product Classification Set, administration, intravascular - Product Code FPA
Product STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
Code Information Product codes: 473547 and 473549  lot #s and expiration dates: 61356774, 1/31/2019; 61362114, 2/28/2019; and  61367665, 3/31/2019.
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information Contact Customer Support
610-596-2870
Manufacturer Reason
for Recall		 Complaints were received that reported the stopcock of some Stopcock Extension Sets are assembled in the reverse position, resulting in the stopcock being closed when set in the open position and vise versa.
FDA Determined
Cause 2		 Process control
Action An urgent medical device correction notification, dated June 3, 2014, describing the product, problem, and actions to be taken, was sent to end users and distributors.
Quantity in Commerce 10,835
Distribution USA (nationwide) including the states of PA, IL, NC, FL, IL, CA, CO, NE, LA, NC, LA, VA, TN, NE, TX, and KS.
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 OF AMERICA, INC.
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