Recall Z-0468-2019 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Arrow International Inc
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 infec
| Date | Sep 21, 2018 |
| Status | Terminated |
| Reason | 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 . |
| Root cause | Employee error |
| Action | Urgent Medical Device Notification letters dated 9/21/18 were distributed to customers. |
| Quantity | 3640 |
| Distribution | US Nationwide distribution in the states of CA, FL, ID, IL, MI, NC, NJ, PA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993691 | ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER Arrow Intl., Inc., Mar 8, 2000 |