Devices

Device Recall The Arrow Percutaneous Sheath Introducer

Model / Serial
Lot Numbers: (1) 13F17D0188, 13F17E0570; (2) 13F17E0660
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
Product Description
Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-29903-UCD
Manufacturer
Arrow International Inc
1 Event
- Recall of Device Recall The Arrow Percutaneous Sheath Introducer

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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