Z-2155-2017 Class II Terminated
FDA device recall Z-2155-2017 was initiated by B Braun Medical Inc on April 10, 2017 and is designated Class II. 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. The recall status is terminated (terminated February 2, 2018). Affected quantity: 417,600 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 31, 2017
- Initiation Date
- April 10, 2017
- Termination Date
- February 2, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 417,600 units
Product Description
CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
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.
Distribution Pattern
United States Nationwide distribution
Code Information
Lot # 1240156001, 1240156002, 1240156003, 1240156004, 1370249001, 1370251101, 1370257101, 1370259201, 1370268401, 1370270401, 1370273801, 1470311101, and 1570315301