Device product
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.
Z-2304-2017
Product summary
- Event
- Event 76937
- Status
- Terminated
- Classification
- Class II
- Quantity
- unknown-firm reports total devices distributed 43,394
- Official record key
device-enforcement:Z-2304-2017
Official wording
Reason: 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.
Code information: Material number ASK-29803-MM
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
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.