FDA-Device2018-03-28Class II

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.

Arrow International Inc
Hazard

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.

Sold states
Nationwide Distribution
Affected count
18,124 total
Manufactured in
2400 Bernville Rd, N/A, Reading, PA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1159-2018

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