FDA-Device2017-06-14Class II

Arrow¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature

Arrow International Inc
Hazard

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

Sold states
Nationwide Distribution
Affected count
unknown-firm reports total devices distributed 43,394
Manufactured in
2400 Bernville Rd, N/A, Reading, PA, United States
Products
Arrow¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2290-2017

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