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-2293-2017Don't want to check this manually?
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