Recall Z-2488-2010 ยท DYB Introducer, Catheter
Arrow International Inc
MAC Two-Lumen Central Venous Access kit with Integral Hemostasis Valve for use with 7 - 8 Fr. Catheters
| 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. |
| Quantity | 16 |
| 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
| K002507 | TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT Arrow Intl., Inc., Mar 21, 2001 |