FDA-Device2017-06-14Class II

Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7 - 7.5¿¿Fr. Catheters The Arrow Percutaneous Sheath Introducer permits venous access and catheter introduction to the central ciruclation

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
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7 - 7.5¿¿Fr. Catheters The Arrow Percutaneous Sheath Introducer permits venous access and catheter introduction to the central ciruclation

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2293-2017

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