Recall Z-0787-2010 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. (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 | 149 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
| K993691 | ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER Arrow Intl., Inc., Mar 8, 2000 |