Device product
CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
Z-2155-2017
Product summary
- Event
- Event 77112
- Status
- Terminated
- Classification
- Class II
- Quantity
- 417,600 units
- Official record key
device-enforcement:Z-2155-2017
Official wording
Reason: 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.
Code information: Lot # 1240156001, 1240156002, 1240156003, 1240156004, 1370249001, 1370251101, 1370257101, 1370259201, 1370268401, 1370270401, 1370273801, 1470311101, and 1570315301
Distribution pattern: United States Nationwide distribution
Derived failure modes
-
Sterility assurance
compromised sterility