Recall Z-1030-2015 ยท OBJ Catheter, Ultrasound, Intravascular
Arrow International Inc
Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
| Date | Jan 29, 2015 (initiated Jan 9, 2015) |
| Status | Terminated |
| Reason | Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated. |
| Root cause | Packaging process control |
| Action | Arrow International, Inc. (Arrow) sent notification letters, dated January 9, 2015, to alert their direct account customers that it may be necessary to obtain an alternate Biopatch Dressing if a kit is used that contains an incorrectly sized Biopatch Dressing. Due to the inconvenience, Arrow will reimburse customers $7.50 per kit received. |
| Quantity | 4484 |
| Distribution | US (nationwide) and PR. |
| FDA record | Open on fda.gov |