Devices

Device Recall Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier

Model / Serial
Material number: ASK-09803-WBH1, ASK-09903-KH, CDC-09803-1A Device Listing E433883
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US (nationwide) and Canada
Product Description
1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter || 2) Arrow PSI Kit
Manufacturer
Arrow International Inc
1 Event
- Recall of Device Recall Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier

Manufacturer

Arrow International Inc

Manufacturer Address
Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
Manufacturer Parent Company (2017)
Teleflex Incorporated
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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