FDA-Device2014-06-11Class II
Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
Arrow International Inc
Hazard
Arrow is recalling the Arrow¿ Percutaneous Sheath Introducer Kits due to dilator tip damage noted during internal inspection. Dilator tip damage has the potential to result in vessel damage.
Sold states
Worldwide Distribution - USA (nationwide) and Canada.
Affected count
15424
Manufactured in
2400 Bernville Road, Reading, PA, United States
Products
Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1713-2014Don't want to check this manually?
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