Recall Z-1879-2017 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Arrow International Inc
Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-t
| Date | Apr 10, 2017 (initiated Mar 17, 2017) |
| Status | Terminated |
| Reason | Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover. |
| Root cause | Process control |
| Action | Arrow International mailed an Urgent Medical Device Notification Letter dated April 4, 2017, to affected customers to inform them of the issue. Customers were asked to discontinue use immediately and return product by completing the enclosed Recall Acknowledgement Form then emailing it to recalls@teleflex.com or faxing it to 1-855-419-8507. A Customer Service Representative will provide a Return Goods Authorization Number for the products' return. For questions regarding this recall call 866-246-6990. |
| Quantity | 310 units |
| Distribution | US Distribution to NJ, IL, and PA |
| 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 |