Device product
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7 - 7.5¿¿Fr. Catheters The Arrow Percutaneous Sheath Introducer permits venous access and catheter introduction to the central ciruclation
Z-2293-2017
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-2293-2017
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-09801-ST
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.