Recall Z-2155-2017 ยท FPA Set, Administration, Intravascular
B Braun Medical Inc
CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
| Date | Apr 10, 2017 |
| Status | Terminated |
| 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. |
| Root cause | 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 | 417,600 units |
| Distribution | United States Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112636 | CYTOGUARD(TM) CLOSED LUER CONNECTOR B.Braun Medical, Inc., Nov 26, 2011 |