—#155027

Product

CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K112636
Affected lot / code info: Lot # 1240156001, 1240156002, 1240156003, 1240156004, 1370249001, 1370251101, 1370257101, 1370259201, 1370268401, 1370270401, 1370273801, 1470311101, and 1570315301

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: B Braun Medical Inc
Address: 200 Boulder Dr, Breinigsville, Pennsylvania 18031-1532

Distribution

Distribution pattern: United States Nationwide distribution

Timeline

Recall initiated: 2017-04-10
Terminated: 2018-02-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155027. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.