Recall Z-1082-2015 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Arrow International Inc
ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.
| Date | Feb 10, 2015 (initiated Jan 2, 2015) |
| Status | Terminated |
| Reason | Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user. |
| Root cause | Process control |
| Action | An urgent Medical Device Recall Notification, dated January 2, 2015, was sent to end users requesting they check their inventory and return affected product per Arrow's instructions. |
| Quantity | 1195 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071538 | ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER Arrow International, Inc., Aug 30, 2007 |