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.
FDA Recall Z-1618-2013 · Posted 2013-06-28
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Recalling FirmBard Access Systems
Recall StatusTerminated
Product CodeKMK
Date Initiated2013-06-10
Date Terminated2014-05-21
Product Quantity3,875 units.
Reason for Recall
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 cathet
Firm Action
On 6/18/13, an "Urgent Kit Recall" notification letter was mailed to all customers informing them of the recall and instructing the consignee to remove and return any affected product lot numbers to Bard Access Systems through return goods authorization. Customers may contact 800-290-1689 if questions.
Root Cause
Packaging
Distribution Pattern
National and Global distribution (Europe, European Economic Area, Argentina, China, and Brazil).
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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