Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use.
Enforcement
- Recall Number
- Z-0468-2019
- Event ID
- 81242
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Arrow International Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 21, 2018
- Initiation Date
- September 21, 2018
- Classification Date
- November 14, 2018
- Termination Date
- September 23, 2020
- Address
- 2400 Bernville Rd, Reading, PA, 19605-9607, United States
Description
Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use.
The products labeling contains inconsistencies. In certain instances, the lidstock, banner card and shipper label state that the Spring Wire Guide (SWG) within is .032 rather than the correct SWG size .025 . For other lots in scope the lidstock correctly states the SWG size .025 however the banner card states the incorrect SWG size .032 .
Lot/Batch Numbers: 13F17E0685 13F17F0562 13F17H0141 13F17K0340 13F18B0119 13R17E0685
US Nationwide distribution in the states of CA, FL, ID, IL, MI, NC, NJ, PA, and WI.
3640