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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Event Detail

Event ID 65202
Product Type Devices
Status Ongoing
Recalling Firm Bard Access Systems
City Salt Lake City
State UT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-10
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern National and Global distribution (Europe, European Economic Area, Argentina, China, and Brazil).

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock® device provides stabilization for compatible medical tubes and catheters. Lot JUWJF283 Class II BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly used during manufacture. The absence of the hydrocolloid strip on the bottom may pose an incremental risk including localized skin irritation. Missing directional arrow may lead to mis-orientation of the StatLock stabilization which may impact the securement of the catheter. 3,875 units. Z-1618-2013
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