Z-2285-2017 Class II Terminated
FDA device recall Z-2285-2017 was initiated by Arrow International Inc on March 20, 2017 and is designated Class II. 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. The recall status is terminated (terminated December 18, 2018). Affected quantity: unknown-firm reports total devices distributed 43,394.
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
Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure Injectable P1CC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the An-owEVOLUTIONTM Pressure Injectable P1CC may not exceed 300 psi. Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization and thrombus accumulation on catheter surfaces. Antimicrobial and antithrombogenic effectiveness were evaluated using in vitro and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections or vein thrombosis
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-45552-SPH