FDAFDA · Food and drugs·Recall number Z-1618-2013
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.
Published July 10, 2013 · Recall initiated: June 10, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bard Access Systems
- Distributor
- National and Global distribution (Europe, European Economic Area, Argentina, China, and Brazil).
- Lot
- Lot JUWJF283
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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