Recall Z-2491-2010 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Arrow International Inc
Multi-Lumen Pressure Injectable Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue PLUS Catheter and Sharps Safety Features
| Date | Sep 25, 2010 (initiated Jul 29, 2010) |
| Status | Terminated |
| Reason | Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle |
| Root cause | Mixed-up of materials/components |
| Action | The recalling firm issued an Urgent Medical Device Recall letter dated 7/23/2010 along with a a recall acknowledgement and stock status form. |
| Distribution | The product was shipped to medical centers and hospitals nationwide and to Australia, New Zealand, and Europe. |
| 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 |