Z-2262-2017 Class II Terminated
FDA device recall Z-2262-2017 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: 43,394 units.
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
- 43,394 units
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
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