Devices

Device Recall Super ArrowFlex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port

Model / Serial
Catalog # PH-09806 -- Lot numbers RF7101122, RF8069650, F8124062, RF0017914, RF0091936
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution: USA including states of: PA and NJ.
Product Description
Percutaneous Sheath Introducer Kit || Intended usage: Permits venous access and catheter introduction to the central circulation system
Manufacturer
Arrow International Inc
1 Event
- Recall of Device Recall Super ArrowFlex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port

Manufacturer

Arrow International Inc

Manufacturer Address
Arrow International Inc, 2400 Bernville Road, Reading PA 19605
Manufacturer Parent Company (2017)
Teleflex Incorporated
Source
USFDA

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