FDA-Device2018-03-28Class II
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. 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
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1160-2018Don't want to check this manually?
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