Cytoguard(Tm) Closed Luer Connector

• • Terminated Z-2155-2017 FDA Class II ·initiated 10 Apr 2017

  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.

510(k) Number

K112636 ↗

FDA Product Code

FPA

FDA applicant

B.Braun Medical, Inc.

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from B. Braun Medical Inc. →