FDAFDA · Food and drugs·Recall number Z-0982-2017
StatLock¿ CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may contain additional components such as a foam pad with a pigtail clip. Product Usage: The StatLock¿ PICC Plus and StatLock¿ CV Plus catheter stabilization devices are suture-free stabilization devices for peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) respectively.
Published January 18, 2017 · Recall initiated: December 9, 2016
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 announces a voluntary field action for the StatLock¿ Catheter Stabilization Devices because some single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bard Access Systems
- Distributor
- Worldwide Distribution - US Nationwide
- Lot
- Lot Number: JUZKF615 & JUAPF369.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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