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.
Recall
- Recall Number
- Z-0468-2019
- Event Number
- 81242
- Firm
- Arrow International Inc
- FEI Number
- 3015859709
- Product Code
- FOZ
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- September 21, 2018
- Terminated
- September 23, 2020
- Address
- 2400 Bernville Rd, Reading, PA, 19605-9607
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 .
Urgent Medical Device Notification letters dated 9/21/18 were distributed to customers.
US Nationwide distribution in the states of CA, FL, ID, IL, MI, NC, NJ, PA, and WI.
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