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U.S. Department of Health and Human Services

Class 2 Device Recall CytoGuard Closed Luer Connector

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  Class 2 Device Recall CytoGuard Closed Luer Connector see related information
Date Initiated by Firm April 10, 2017
Create Date May 23, 2017
Recall Status1 Terminated 3 on February 02, 2018
Recall Number Z-2155-2017
Recall Event ID 77112
510(K)Number K112636  
Product Classification Set, administration, intravascular - Product Code FPA
Product CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
Code Information Lot #  1240156001, 1240156002, 1240156003, 1240156004, 1370249001, 1370251101, 1370257101, 1370259201, 1370268401, 1370270401, 1370273801, 1470311101, and 1570315301
Recalling Firm/
Manufacturer
B Braun Medical Inc
200 Boulder Dr
Breinigsville PA 18031-1532
For Additional Information Contact
610-266-0500
Manufacturer Reason
for Recall
B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connector due to a potential for some blisters to be punctured resulting in a compromised sterility barrier.
FDA Determined
Cause 2
Nonconforming Material/Component
Action B. Braun mailed an Urgent Medical Device Recall Notice to affected customers to inform them of the issue. Customers were asked to determine their current inventory and to not destroy any of the product; however, product should be discontinued immediately and quarantined and return the acknowledgement form for product return.
Quantity in Commerce 417,600 units
Distribution United States Nationwide distribution
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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