FDA-Device2018-03-28Class II
Percutaneous Sheath Introducer Kit with 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.
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 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-1158-2018Don't want to check this manually?
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