Devices

Device Recall Percutaneous Sheath Introducer Kit with ARROWgard Blue (R) Sheath,

Model / Serial
Product number ASK-29803-SJH. Lot numbers RF9044900 and RF9068155
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
The products were shipped to distributors in GA, MD, and VA.
Product Description
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr Catheters. The product is shipped in cases containing 5 catheters (contains Q-Syte)
Manufacturer
Arrow International Inc
1 Event
- Recall of Device Recall Percutaneous Sheath Introducer Kit with ARROWgard Blue (R) Sheath,

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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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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