Z-2293-2017 Class II Terminated

Recalled by Arrow International Inc — Reading, PA

Recall Details

Product Type
Devices
Report Date
June 14, 2017
Initiation Date
March 20, 2017
Termination Date
December 18, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
unknown-firm reports total devices distributed 43,394

Product Description

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

Reason for Recall

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.

Distribution Pattern

Nationwide Distribution

Code Information

Material number ASK-09801-ST