Z-2267-2017 Class II Terminated
FDA device recall Z-2267-2017 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 Jugular Axillo-Subclavian Central CThe CG+Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central veinatheter (JACC) Product
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 CDC-41541-JX1A