Recall Z-0783-2010 ยท DYB Introducer, Catheter
Arrow International Inc
MAC (TM) Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7 - 7.5 Fr Catheters. The product is shipped in cases containing 5 catheters (contains Q-Syte)
| Date | Mar 5, 2010 (initiated Nov 24, 2009) |
| Status | Terminated |
| Reason | Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued an Urgent Medical Device Recall letter dated 11/24/09 to their customers informing them of the problem the need to return any kits in inventory and notify their customers of the recall. For additional information customers can contact the Customer Service Department at 800-523-8446. |
| Quantity | 117 kits |
| Distribution | The products were shipped to distributors in GA, MD, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011761 | MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT Arrow Intl., Inc., Oct 31, 2001 |