CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
This recall has been terminated (originally issued April 10, 2017).
- Company
- B Braun Medical Inc
- Recall Initiated
- April 10, 2017
- Terminated
- February 2, 2018
- Recall Number
- Z-2155-2017
- Quantity
- 417,600 units
- Firm Location
- Breinigsville, PA
- Official Source
- View on FDA website ↗
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
United States Nationwide distribution
Lot / Code Info
Lot # 1240156001, 1240156002, 1240156003, 1240156004, 1370249001, 1370251101, 1370257101, 1370259201, 1370268401, 1370270401, 1370273801, 1470311101, and 1570315301
Root Cause
Nonconforming Material/Component
Action Taken
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.