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Terminated

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

FDA Recall Z-2155-2017 · Posted None

Recalling FirmB Braun Medical Inc
Recall StatusTerminated
Product CodeFPA
Date Initiated2017-04-10
Date Terminated2018-02-02
Product Quantity417,600 units

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

United States Nationwide distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112636CYTOGUARD(TM) CLOSED LUER CONNECTORB.Braun Medical, Inc. · 2011-11-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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