RecallDepth

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

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

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.

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