Bard Access Systems recalls StatLock¿ CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit with a skin protectant pad and…

Recall date

December 9, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0982-2017

FDA classification

Class II

Brand / firm

Bard Access Systems

Sold / distributed

Worldwide Distribution - US Nationwide

Why it was recalled

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.).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.