Recall Z-2155-2017— B Braun Medical Inc

Name: FDA recall Z-2155-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-10

Class II · Terminated

Class II FDA medical device recall by B Braun Medical Inc, initiated 2017-04-10, terminated 2018-02-02. It names one FDA 510(k) clearance: K112636. Product: CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case). 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..

Recalling firm: B Braun Medical Inc
Classification: Class II
Status: Terminated
Initiated: 2017-04-10
Terminated: 2018-02-02
Firm location: Breinigsville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K112636 — CYTOGUARD(TM) CLOSED LUER CONNECTORB.Braun Medical, Inc.·cleared 2011-11-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.