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 Arrow¿ Percutaneous Sheath Introducer permits venous access and catheter introduction to the central circulation. The ARROWg+ard¿ antimicrobial surface is intended to help provide protection against sheath-related infections. The sheath is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
Enforcement
- Recall Number
- Z-2304-2017
- Event ID
- 76937
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Arrow International Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 14, 2017
- Initiation Date
- March 20, 2017
- Classification Date
- June 6, 2017
- Termination Date
- December 18, 2018
- Address
- 2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States
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 Arrow¿ Percutaneous Sheath Introducer permits venous access and catheter introduction to the central circulation. The ARROWg+ard¿ antimicrobial surface is intended to help provide protection against sheath-related infections. The sheath is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
Material number ASK-29803-MM
Nationwide Distribution
unknown-firm reports total devices distributed 43,394