Medical device recalls Moderate risk

Arrow International Inc recalls Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features…

Recall date
November 14, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1159-2018
FDA classification
Class II
Brand / firm
Arrow International Inc
Sold / distributed
Nationwide Distribution

Why it was recalled

Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.

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

What was recalled

Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access and catheter introduction to the central circulation.

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